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Biocompatibility and corrosion resistance of metallic biomaterials

  • Sadaqat Ali

    Dr. Sadaqat Ali obtained his BSc in mechanical engineering from UET, Peshawar, Pakistan, in 2007, his MSc from Malardalens University, Sweden, in 2011 and his PhD in mechanical engineering from Universiti Teknologi PETRONAS, Malaysia, in 2020. His current research includes advanced materials development via additive manufacturing and powder metallurgy for aerospace and biomedical applications. He is currently working as an assistant professor at SMME, National University of Sciences & Technology, Islamabad, Pakistan.

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    , Ahmad Majdi Abdul Rani

    Dr. Ahmad Majdi Abdul Rani is currently an associate professor in Universiti Teknologi Petronas, Malaysia. He completed his PhD in mechanical and manufacturing from Loughborough University, UK. He obtained his MSc in industrial engineering and his BSc in manufacturing engineering from Northern Illinois University, USA. His area of expertise is in advanced manufacturing of biomedical implants, reverse engineering, CAD/CAM and PM-EDM. He has graduated nine PhD and six MSc candidates and has published numerous articles in high index journals.

    , Zeeshan Baig

    Dr. Zeeshan Baig received his MSc engineering degree (metallurgy and materials) from U.E.T, Pakistan, in 2006. He received his PhD in mechanical engineering from Universiti Teknologi PETRONAS in 2019. His current research interests include advanced materials development via additive manufacturing for aerospace, automotive and biomedical applications. He authors various international scientific publications, including articles in journals and conference proceedings.

    , Syed Waqar Ahmed , Ghulam Hussain

    Dr. Ghulam Hussain is currently working as an associate professor at GIK Institute of Engineering Sciences & Technology, Pakistan. His research interests include advanced materials, advanced manufacturing, corrosion and sustainability. He is the author of numerous review and research articles. He is actively involved in research with renowned international universities. He has been listed as “National Productive Scientist” and selected as a Foreign Expert on Manufacturing in China and a Foreign Research Member of King Abdul–Aziz University.

    , Krishnan Subramaniam

    Krishnan Subramaniam studied in Ipoh, Perak. He has post-graduate degrees (MSc and MEng) in mechanical engineering from Universiti Teknologi PETRONAS (UTP) and University Tunku Abdul Rahman (UTAR), Malaysia. He joined as a senior lecturer at Manipal International University in 2016 and obtained his PhD degree from Universiti Teknologi PETRONAS in 2017. He has proposed a new rehabilitation model for human beings using smart materials and done a lot of clinical studies in hospitals.

    , Sri Hastuty and Tadamilla V.V.L.N. Rao
Published/Copyright: August 27, 2020

Abstract

Biomaterials play a significant role in revolutionizing human life in terms of implants and medical devices. These materials essentially need to be highly biocompatible and inert to the human physiological conditions. This paper provides an in-depth, critical and analytical review on the previous research work and studies conducted in the field of metals and alloys used as implant materials including stainless steel, titanium and its alloys, cobalt chromium and others. Since the manufacturing of medical implants relies on selected grades of biomaterials, metals play a significant role in biomaterials market. This paper focuses on highlighting some basic principles of manufacturing implant materials underlying composition, structure and properties of these materials. Finally, attention is also given to the role of these implant materials on the betterment of human life in terms of their failures by critically analysing these materials.

1 Introduction

The replacement of damaged organs, tissues, blood vessels or complete body parts has enhanced the quality and life span of mankind. The broad applications of treatment procedures have helped to prolong and save human life resulting in the betterment of society and health community. The decrease in surgical risks has encouraged the growth of more complex procedures for implantation during recent times. The availability of homogeneous or suitability of traditional autogenous prosthetic elements is very limited. This constraint of limited material choice initiates the need of developing synthetic materials that can be used as implant materials. These materials are expected to provide a better solution in terms of their application and perform well within the body specially while in contact with the body fluid (Bhat 2002). The commonly used implants find their applications in orthopaedics, dentistry, cardiovascular surgeries, ophthalmology, neurosurgery, plastic and reconstructive surgery and many others as shown in Figure 1.

Figure 1: 
					Applications of biomaterials in the human body (Manivasagam et al. 2010).
Figure 1:

Applications of biomaterials in the human body (Manivasagam et al. 2010).

2 Biomaterials

A biomaterial can be defined as a substance that is pharmacologically inert, able to interact with biological system and can be used in medical application (Grainger 1999; Sunija 2018). The biomaterial in the form of implants is expected to incorporate with a living scheme and interact with biological system to replace or supplement functions of organs or living tissues (Williams 2009). The research on biomaterials increased tremendously after the first summit in 1969 on progress and growth of biomaterials (Lemons et al. 2015). In early 1960s, the emphasis was placed on biomaterials to be chemically stable and remain inert while interacting with human physiological conditions. Since then, there is a constant strive to create advanced new materials for implantation. A right selection of biomaterial for implantation is very vital for its longevity concerning its corrosion resistance, biocompatibility, wear resistance, mechanical properties, economics and ease of manufacturing (Ali et al. 2019a,b,c; Aliyu et al. 2017 2018; Kang and Fang 2018a,b). These important considerations have been summarized in Figure 2 and discussed in the following sections.

Figure 2: 
					Factors affecting performance of implant material.
Figure 2:

Factors affecting performance of implant material.

2.1 Biocompatibility of biomaterials

The biocompatibility of a material can be defined as its response to tissue interaction in a biological system (Anderson et al. 1996). It determines the suitability and fitness of a biomaterial for its usage in implants or medical devices. The biocompatibility ensures that the material does not have any hazardous effects while placed in human physiological conditions (Williams 2016). The relationship of cells and tissues with implant material is covered by its biocompatibility (Williams 1986). The materials used to produce implants are expected to be highly biocompatible and nontoxic. They are required to be stable in the human body without causing any inflammatory or allergic reactions (Williams 2008). The biocompatibility ensures that the implant material is nontoxic and that it does not cause any inflammation or allergic reactions (Manam et al. 2017).

The Food and Drug Administration has defined biocompatibility in terms of its harmlessness to the host (Von Recum 1998). It states that biomaterial should be trouble free, does not cause any allergic reactions or inflammation and brings no measurable harm to the host (Starling et al. 2011). Thus, the design of material along with its biocompatibility is equally important in manufacturing of implants (D`Angelo et al. 2010). The implant material is expected to have zero influence on the bones, soft tissues, cells, body fluids and ionic composition of blood (Patel and Gohil 2012). This is related not only to the adverse effects of implant material but also to the toxicity of the material and its response to the human body (Geetha et al. 2009; Navarro et al. 2008). The main elements of human body are oxygen and carbon along with other trace elements as shown in Table 1.

Table 1:

Essential elements in the human body (Manam et al. 2017; Niinomi 1999).

Element Weight percent (Wt. %) Atomic weight percent (At. %)
Oxygen (O) 65.00 25.50
Carbon (C) 18.50 9.50
Hydrogen (H) 9.50 63.00
Nitrogen (N) 3.30 1.40
Calcium (Ca) 1.50 0.31
Phosphorus (P) 1.00 0.22
Potassium (K) 0.40 0.06
Sulphur (S) 0.30 0.05
Sodium (Na) 0.20 0.30
Chlorine (Cl) 0.20 0.03
Magnesium (Mg) 0.10 0.10
Trace elements <0.01 <0.01

Thus, considering these factors, bioactive materials are widely selected in implant manufacturing since they help in high integration with human body.

The commonly used biomaterials can be categorized based on their relatively biocompatibility. The 316L stainless steel is biocompatible but its biocompatibility is slightly less than that of titanium- and cobalt-based alloys due to its inferior corrosion resistance. The biocompatibility relation of these biomaterials has been summarized in Figure 3.

Figure 3: 
						Relative biocompatibility of commonly used biomaterials.
Figure 3:

Relative biocompatibility of commonly used biomaterials.

Therefore, the alloying elements should be selected by considering their ability to survive physically in the human body as per previous research since no material can be totally inert after a certain period (Manam et al. 2017). Therefore, the implant or medical device should be made of those alloys or elements that are nontoxic. None of the metals are totally inert or nontoxic. Therefore, the alloying elements should be almost inert or found as trace elements in the human body. The biocompatibility of some commonly used alloys and pure biocompatible metals has been shown in Figure 4.

Figure 4: 
						(a) Cytotoxicity of various metals and (b) correlation among polarization resistance and biocompatibility of metals (Niinomi 1999).
Figure 4:

(a) Cytotoxicity of various metals and (b) correlation among polarization resistance and biocompatibility of metals (Niinomi 1999).

2.2 Corrosion resistance of biomaterials

The corrosion resistance is an important aspect of implant materials. The implants face electrochemical attack by the hostile electrolytic environment and get corroded in human body fluids with the passage of time (Singh and Dahotre 2007). The corrosive environment includes blood and body fluids that normally contain chlorine, sodium, plasma, proteins and mucin. The corrosion products of implanted material are transferred to other body parts built up in the cells and tissues next to the implant (Okazaki and Gotoh 2005).

Among the corrosion types, galvanic, crevice and pitting corrosion are the most common types of corrosion. It is to be noted here that these types of corrosion take place independently and do not depend on each other. They can occur simultaneously as well, and, in some cases, they can be an extension to an existing type of corrosion. The corrosion effects on the dental implant and abutment are shown in Figure 5. It indicates that the electrochemical process between the implant and the superstructure associated with it has been corroded due to pitting corrosion. This is because of galvanic corrosion that took place due to ion exchange between prosthetic parts and implants. The pitting corrosion often occurs at the connection of abutment and implant. The crevice corrosion takes place due to and an increase in the concentration of chloride ions and reduction in pH values. This creates an acidic environment in this vicinity (Noumbissi et al. 2019). The increased acidity at the peri-implant area and the depletion of passive oxide layer increases the susceptibility of corrosion attack. The exposure to oxygen has been reported to be the cause of depletion of passive oxide layer which previously served as the resistance to the corrosion of the implant (Zardiackas et al. 2003).

Figure 5: 
						(a) Implant–abutment connection corrosion and (b) superstructure denture corrosion (Noumbissi et al. 2019).
Figure 5:

(a) Implant–abutment connection corrosion and (b) superstructure denture corrosion (Noumbissi et al. 2019).

The corrosion of the implant material decreases the life span of implants leading to repeated surgery (Hallab et al. 2001). The physiological condition of the human body is quite complex, and the material that is passive or inert in air can resist this corrosion (Brayda-Bruno et al. 2001). Among the available materials, stainless steel is considered as the most corrosion resistant metal, but even this material gets corroded when used as an implant material. It has been associated with chronic allergies and toxic reactions in the human body (Jacobs et al. 1998a,b, 1999). The concentration level of oxygen varies in different parts of the human body, whereas the corrosion resistance of implant material verifies the lasting achievement. Due to oxidation and acidic erosion, an implant that does well in one part may get corroded in another part of the human body.

The corrosion of an implant material is accelerated by the aqueous ions of human body fluids which normally contain sodium (Na), chloride (Cl), 0.9% saline and other ion traces (Sumita et al. 2003). The human body, combined with variations in the ions strength due to deposition of ions or increased high blood pressure, can result in a critical situation for any implant. The partial pressure of oxygen in the human body corresponds to one quarter of the partial pressure of atmospheric oxygen. This lesser partial pressure accelerates the corrosion of implant material and delays the formation of passive oxide film layer if the implant is broken or removed (Chen and Thouas 2015; Sumita et al. 2003). This necessitates improved corrosion resistance of implant materials with minimal or no leaching of metal ions from the implant. The implants are expected to be stable in human physiological conditions for long time with a service period of 30 years or more (Harun et al. 2018; Ureña et al. 2018).

The surface oxide film that is formed on implant surface plays an important part in controlling leaching of metal ions. Its behaviour and composition changes with the release of ions due to the reaction between tissues and surface of implant material (Radenković and Petković 2018). The surface oxide film controls corrosion resistance of the implant and plays a vital part in tissue compatibility as well (Munir and Walsh 2016). The implant materials are tested for both in vitro and in vivo studies before implant application. The in vitro corrosion studies are performed in simulated body fluids such as Hank’s solution, Ringer’s solution and artificial saliva solution (Gal et al. 2001). The surface oxide film of biomaterials is usually not stable all the times. Its analysis is very important in understanding the corrosion phenomenon taking place in the human body. The analysis of the formation of surface oxide film for commonly used biomaterials is in Table 2.

Table 2:

Surface oxide films analysis on commonly used biomaterials (Manivasagam et al. 2010).

Metallic biomaterial Surface oxides Surface analysis
Austenitic 316L stainless steel Oxides of iron, chromium, manganese, molybdenum and nickel
  • – The surface oxide film comprises OH ions.

  • – The surface is enriched with iron and chromium.

  • – The oxides are oxyhydroxidized or hydrated.

  • – Nickel is absent when tested in chloride solutions and air

  • – Molybdenum observed on surface is very less.

Titanium Ti0+, Ti2+, Ti3+, Ti4+
  • – Ti3+ oxide formation on the surface is more favourable than the Ti2+ oxide.

  • – Ti4+ oxide is observed on the surface of the outer most layer.

  • – The oxidation process for Ti2+ and Ti3+ proceeds to the uppermost part of the surface film.

Titanium alloys TiO2-based oxide

Ti and Zr oxides

TiO2
  • – Minimal amounts of nickel metal and oxide states.

  • – Ti and Zr oxides uniformly distributed. The oxide film thickness increases with increasing Zr content.

  • – The alloying element V not detected, whereas the surface consists of hydroxyl groups and Al2O3.

  • – Low concentrations of hydroxyl groups, NiO and metallic nickel detected on the surface.

Co–Cr–Mo alloy Oxides of Co and Cr without Mo
  • – The surface oxide film contains ions of OH.

  • – The oxides are oxyhydroxidized or hydrated.

  • – Co and Cr are dispersed mostly at inner oxide layer.

The leaching of metal ions from the implant affects several biological parameters. It initiates corrosion and erosion of the material, induces brittleness and eventually leads to the fracture of implants. The effects of corrosion due to various elements of biomaterials have been presented in Table 3.

Table 3:

Corrosion effects of various elements of biomaterials.

Biomaterial element Effect of corrosion on the human body
Nickel Greatly affects the skin leading to dermatitis
Chromium Disturbs central nervous system and creates ulcers
Cobalt Inhibits iron (Fe) from being absorbed into the blood stream causing anaemia B
Vanadium Highly toxic to the human body in its elementary state
Aluminium Its accumulation in the human body leads to Alzheimer disease and has epileptic effects

The corrosion effects indicate the possible harms that can take place in the human body. The release of corrosion products and leaching of metal ions can even lead to adverse biological reactions in the tissues surrounding the implants and can also damage other body organs leading to their malfunctioning (Williams 2003). The failure of implants has been studied by many researchers to investigate the cause of their failure. The analysis of failure from two basic metallic alloys, 316L stainless steel and Ti–6Al–4V, has been presented in Figure 6.

Figure 6: 
						Analysis of implant material failure.
Figure 6:

Analysis of implant material failure.

The analysis indicates that the main cause of failure of the implant is due to corrosion and erosion corrosion (42%), followed by fatigue via ductile-type failure (25%). The failure due to inclusion and stress gaps and traces of production impurities contribute almost equally (16 and 17% each) for the implant failures.

The only solution to enhance corrosion resistance is to select appropriate and better quality materials along with suitable coating. The improvement of material properties by alloying with suitable additives is evitable as far as the corrosion resistance of the biomaterial is concerned. Moreover, the improvement of surface properties is another important aspect in increased corrosion resistance of the implant.

The corrosion rate of a material can be defined as the amount of metal removed because of corrosion. An acceptable corrosion rate depends on the possible effect of corrosion on the implant’s functionality, its application and cost of the material (Eliaz 2019). The polarization curves for commonly used biomaterials have been presented in Figure 7.

Figure 7: 
						Polarization curves showing corrosion rate of biomaterials (Eliaz 2019).
Figure 7:

Polarization curves showing corrosion rate of biomaterials (Eliaz 2019).

2.3 Metal ions release and adverse tissue reactions of biomaterials

Metal ions may be released from the implant material during their retention in the human body (Jones et al. 2017). This leaching of metal ions takes place due to low wear and corrosion resistance which is nonbiocompatible in nature (Hallab et al. 2005). Among the available biomaterials, titanium and its alloys have been widely used in implant applications (Bosshardt et al. 2017). They are highly corrosion resistant both in saline as well as in acidic environments along with improved mechanical and physical properties (Rasouli et al. 2018). Their improved corrosion resistance owes to the stable oxide layer (TiO2) that makes this material highly corrosion resistant (Osman and Swain 2015). However, this material is still vulnerable to corrosion attack if this layer gets removed and does not reconstitute itself. This results in the oxidation of the entire alloy system, and the leaching of metal ions takes place (Noumbissi et al. 2019). The corrosion products are released to the peri-implant soft and hard tissues as shown in Figure 8.

Figure 8: 
						TiO2 layer depletion in Ti–6Al–4V (Noumbissi et al. 2019).
Figure 8:

TiO2 layer depletion in Ti–6Al–4V (Noumbissi et al. 2019).

The titanium ions greatly influence the cell function of lymphocytes and phenotypes, increase the appearance of cytokines in osteoclasts and leads to the differentiation of monocytes into osteoclasts (Cortada et al. 2000). In case of stainless steel, chromium and nickel ions leached out from the implant have been reported to be the cause of type IV hypersensitivity (Harloff et al. 2010). They can initiate various cytotoxic reactions by acting as carcinogens and mutagens (Eliaz 2019). These include increased mutagenicity, decreased enzyme activities, increased carcinogenicity and interference in biochemical pathways. Even a little amount of nickel or other toxic elements in the human body can cause many reactions as reported in patients (Syed et al. 2015). The leaching of nickel in dental materials can badly affect the monocytes and oral mucosal cells in long-term exposures. It has been reported that manganese reacts with human saliva leading to the formation of toxic elements that damage the nervous system and may lead to skeletal disorders (Fretwurst et al. 2018). The possible interrelation between degenerative osteonecrosis and titanium implants has also been reported for the cause of silent inflammation (Lechner et al. 2018).

The quantity of degradation products and their physiochemical properties are helpful in determining their effects on the peri-implant tissues (Noronha Oliveira et al. 2018). The release of metal ions arouses the attraction of macrophages and lymphocytes from the immune mechanism of the human body (Daubert et al. 2018; Rodrigues et al. 2013; Safioti et al. 2017). The inflammatory mediators accompanying peri-implant infections have been related to the release of ions and have been shown in Figure 9.

Figure 9: 
						Degradation process of implant material and ion release (Noumbissi et al. 2019).
Figure 9:

Degradation process of implant material and ion release (Noumbissi et al. 2019).

2.4 Osseointegration of biomaterials

The osseointegration of a biomaterial can be defined as the direct functional and structural connection between the living bone and load-carrying implant surface (Hussein et al. 2015). Osseointegration takes place when tissues and the living bone grow directly onto implant surface (Ellingsen and Lyngstadaas 2003; Westover 2016) as shown in Figure 10.

Figure 10: 
						Osseointegration of titanium implant surface (Westover 2016).
Figure 10:

Osseointegration of titanium implant surface (Westover 2016).

The osseointegration is the process of bone healing whereby new bone growth takes place (Nasab et al. 2010). The topography, chemistry and surface roughness are considered as the major elements for good osseointegration (Parsapour et al. 2012; Subramanian et al. 2012). The surface of implant is very necessary for the interaction of implant with the adjacent bone and is very influential in their mixing together (Mani et al. 2009). The history of osseointegration can be traced back to 1960s when Per-Ingvar Branemark firstly discovered osseointegration. He found the implants not being able to be detached from his experiments on rabbits and dogs (Branemark 1959). In one of his experiments, he placed threaded implants made of pure titanium in rabbits. The implants were hollow with glass rods glued inside as shown in the Figure 11.

Figure 11: 
						Radiogram of a chamber placed in rabbit bone (Albrektsson et al. 2017).
Figure 11:

Radiogram of a chamber placed in rabbit bone (Albrektsson et al. 2017).

The blood vessels along with marrow and bone tissues grew straight through the implant proving his hypothesis (Albrektsson et al. 2017). This led to the discovery of osseointegration which indicates direct contact between bone and foreign material in the form of implants without any interposed soft tissue layers. The osseointegration of biomaterials is a must needed property in some implant applications where the implant needs to integrate properly with tissues and bone (Barfeie et al. 2015), whereas it becomes undesirable in other applications where the implant needs to be removed after some time. In such cases, it becomes very difficult for the surgeons to remove the implant due to tissue and bone integration with the implant material (Hussein et al. 2015; Wennerberg et al. 2015).

2.5 Physical and mechanical properties of biomaterials

The implants and medical devices in dentistry, orthopaedics, cardiovascular, otolaryngology and craniofacial are expected to be stable mechanically, as well as physically. The requirements of their stability include biocompatible, specifically interactive, inert and chemically stable (Hanumantharaju et al. 2012). The biomaterials must possess good mechanical properties including rigidity, elasticity, toughness, strength and fracture resistance (Hermawan et al. 2011). Metals are preferred over polymeric, composite and ceramic biomaterials due to their high ductility, high yield strength and high modulus (Kamachimudali et al. 2003). These high properties make them the ideal material for implantation. The properties of commonly used metallic biomaterials have been formulated in Table 4.

Table 4:

Mechanical properties of metallic biomaterials (Zaman et al. 2015).

Metallic biomaterial Ultimate tensile strength (MPa) Yield strength (MPa) Modulus (GPa)
Stainless steel 465–950 170–750 200
CP–Ti 785 692 105
Ti–6Al–4V 960–970 850–900 110
Co–Cr–Mo 600–1795 275–585 200–300

The combination of excellent mechanical properties helps the implant to bear the load deformations in load-bearing applications. The stresses induced in the biomaterial can lead to fatigue cracks on implant surface. The mechanical damage can then lead to wear of the biomaterial resulting in implant failure and premature removal of prostheses (Wang et al. 2010). The mechanical strength and elastic modulus greatly influence the load distribution between human tissues and the load-bearing implant (Pilliar 2009). It is the requirement of the biomaterial to have similar stiffness to the bone with greater strength to be able to bear the stresses generated due to load (Alvarado et al. 2003).

The forces that are normally experienced by implant materials can be categorized into compressive, tensile and shear components (Mahajan and Kadam 2014). The dental implants are less damaged by the stresses in comparison to other implants of human body. This is due to their smaller size as compared to other implants and lower number of loading cycles, although the failures obey all the laws of mechanics in relation to their smaller size (Lemons et al. 2015).

The reliability and longevity of implants can be determined by its tensile strength, compressive strength, fatigue limit, fracture and wear resistance (Niinomi 2007). The performance of a biomaterial in a specific implant application needs to be carefully assessed before implantation. This includes a vigilant analysis of biomechanics, biochemistry, anatomy and physiology of that part along with physical, mechanical, chemical, biological and environmental aspects of the biomaterial under consideration. This information intervenes to restore the normal function of the human body without any complications. These important aspects of implantation have been highlighted in Figure 12.

Figure 12: 
						Factors influencing the success of an implant.
Figure 12:

Factors influencing the success of an implant.

The mechanical properties of the biomaterials can be increased by mechanical alloying with certain additives and heat treatment methods. These material properties for a certain implant application can be optimized for required strength and ductility (Lemons et al. 2015; Wang et al. 2015). Since the bone can alter its structure in reply to the force applied to it, therefore, the implant material should be designed in such a way as to cope with it for increased performance of implant in connection to the bone.

3 Types of metallic biomaterials

The selection of biomaterial is an important aspect in the manufacturing of implants and biomedical devices. It corresponds to the understanding of device based function and the material properties must be fully evaluated before putting into purpose. The physical, chemical and mechanical properties of the biomaterial serve as the key inputs to the implants and are interrelated to its biological and biomechanical function (Lemons et al. 2015). The most important aspect of biocompatibility depends upon the bulk and surface properties of the biomaterial. Therefore, material selection for a specific implant application must be carefully evaluated. The selection of biomaterial for a certain application depends on various considerations that include material type, its manufacturing, structural design, regulatory and patient-related factors. Among material types, its properties such as resistance to wear, corrosion, degradation and biocompatibility are to be considered. The manufacturing factors include its ease of manufacturing along with the processing conditions. The structural properties of biomaterial mainly include its strength, ductility, fatigue, resistance to deformation, flexural rigidity and mechanical failure.

The metallic biomaterials used for implantation and manufacturing of medical devices have been discussed in the following sections.

3.1 Metallic biomaterials

Metallic materials such as metals and alloys can be traced back to the industrial evolution era of the 19th century, when they were firstly used in the medical applications. The advancement of using metallic materials as an implant material was motivated by the need for better means of implantation in the form of repairing the bone or damaged organs (Chen and Thouas 2015). Since then, several metals and alloys have been used for implantation as per the desired requirements and specifications.

Although many metallic materials are available, only a very few metals and alloys have the capability to be used as implant material due to their biocompatibility and other properties mentioned in the previous sections. The available implantable materials can be classified into four main groups as shown in Table 5.

Table 5:

Classification of metallic biomaterials (Chen and Thouas 2015; Manam et al. 2017).

Metal type Primary application Implants
Stainless steels Dentistry

Orthopaedic

Cardiovascular
  • – Orthodontic wires, dental implants, screws

  • – Orthopaedic implants, femoral prosthesis, reconstructive surgery

  • – Coronary stents, heart valves, cardiovascular stents

Ti-based alloys Dentistry

Orthopaedic

Cardiovascular
  • – Orthodontic wires, dental implants, screws

  • – Orthopaedic implants, orthopaedic prosthesis, skeletal prosthesis, reconstructive surgery, load-bearing implants, hard tissue substitutions.

  • – Coronary stents, heart valves, cardiovascular stents.

Co-based alloys Dentistry

Orthopaedic

Cardiovascular
  • – Orthodontic wires, dental implants, removable partial dentures

  • – Orthopaedic implants, total hip implant, femoral stems, orthopaedic prosthesis, skeletal prosthesis, reconstructive surgery, load-bearing implants.

  • – Coronary stents, heart valves, cardiovascular stents.

Others

Ni–Ti alloys

Ta alloys

Mg alloys
Orthopaedic and cardiovascular

Surgery

Biodegradable implants
  • – Orthopaedic staples, vascular stents, catheter guide wires, artificial heart muscles

  • – Wire sutures for neurosurgery and plastic surgery.

  • – Biodegradable orthopaedic implants.

3.1.1 Stainless steels

Stainless steel can be considered as one of the oldest and first material to be used in the medical field for implant applications (Ali et al. 2019a–c; Alvarado et al. 2003). The name stainless steel designates several iron-based alloys containing chromium and nickel with varying percentages (Davis 2003). The stainless steels are normally categorized into four families as per their crystal structure (Chen and Thouas 2015; Davis 2003). These categories along with their applications have been tabulated in Table 6.

Table 6:

Stainless steel categories and their applications in the medical field (Chen and Thouas 2015).

Stainless steel type Application Examples
Austenitic Hip replacement, short-term implants and medical devices Dental implants, impression trays, cannulas, screws, pins
Ferritic Surgical instruments Guide pins, fasteners, solid handles for instruments
Martensitic Surgical and dental instruments Forceps, scalpels, chisels, dental burs, root elevators
Duplex Not yet applied in the medical field No example

It is evident from the table that except duplex stainless steel, every other type has certain usage in the medical field. Among the remaining three types, austenitic stainless steels find applications in implant manufacturing (Hermawan et al. 2011). Among available stainless steels, 316L stainless steel is the most used implant material due to increased corrosion resistance (Ali et al. 2018, 2019a,b,c; Ratner et al. 2006). This type was discovered by Strauss in 1926, and the chemical composition of 316L stainless steel has been designed in such a way as to attain stable austenitic structure (Disegi and Eschbach 2000; Hermawan et al. 2011). This structure presents numerous advantages including face-centred cubic structure with nonmagnetic nature and improved corrosion resistance (BomBač et al. 2007; Disegi and Eschbach 2000). The implants and medical devices manufactured from stainless steels exhibit good mechanical strength, ductility and cost effectiveness (Asri et al. 2017). The implants manufactured from 316L stainless steel are cheaper than titanium- and cobalt-based alloys by a factor of one fifth to one tenth (Alvarez et al. 2008; Dewidar 2012; Talha et al. 2013). The stainless steels contain chromium with a minimum percentage of 11 wt.% which helps the material from rust in a harsh environment (Chen and Thouas 2015). The increased corrosion resistance is achieved by presence of nickel which helps in stabilizing the austenite formation of iron. This not only improves corrosion resistance but also helps in passive oxide layer formation onto material surface (Davis 2003). The addition of molybdenum helps in further enhancement of the corrosion resistance (Sonnleitner et al. 2010).

Although the stainless steels are widely accepted biomaterials for implant manufacturing, they do not remain stain proof in human physiological conditions. They do not remain corrosion resistant in long-term implantations, thus limiting their usage in temporary devices only (Chen and Thouas 2015). The stainless steel implants have been reported for implant failures in several patients. The premature failure of orthopaedic implant has been shown in Figure 13.

Figure 13: 
							Radiographic image of failed orthopaedic implant (Tavares et al. 2010).
Figure 13:

Radiographic image of failed orthopaedic implant (Tavares et al. 2010).

The failure time of stainless steel implants varies from several months to several years, and it has been reported that the main cause of failure of implants is mainly due to fatigue failure. This is due to poor surface finishing that leads to crevice corrosion and fatigue cracking. The life span can be increased by surface treatment or surface finishing, thereby controlling the fatigue failure of 316L stainless steel implants. In this regard, surface nitriding has been reported as one of the controls for improving surface quality (Ali et al. 2020).

The main alloying elements in 316L stainless steel are iron which serve as the base material in the form of matrix element followed by chromium, nickel, molybdenum and manganese (Doran et al. 1998). The iron is an essential trace element present in the human body. It is found in many cellular enzymes, cells and is also an important part of human haemoglobin (Bertini et al. 1994; Furstner 2016). The iron is considered as an important part of the human body and its deficiency can lead to nutritional deficiencies, iron deficiency anaemia, morbidity and even death (Chen and Thouas 2015; Umbreit 2005; Zimmermann and Hurrell 2007). Although iron is an important element of the human body, its excessive amount in the form of leaching from implant material can increase its concentration in the human blood. This can affect the lipids, proteins, DNA and other cellular components. Its excess can damage the heart and liver cells and lead to liver and heart failure, respiratory distress syndrome, metabolic acidosis, coma and even death if untreated (Cheney et al. 1995; Farina et al. 2013; Sinicropi et al. 2010).

The chromium is considered as one of the important factors in regulating sugar level in the human body. Its deficiency can lead to glycosuria and hyperglycaemia; therefore, its proper concentration is very important for a healthy life (Denizoglu and Duymus 2006; Keinan et al. 2010; Tsuchiya et al. 2002). The minimum percentage of chromium in the stainless steels is ∼11 wt.%. It has a good affinity towards oxygen and forms a passive oxide layer which promotes self-healing if the layer gets depleted away (Bekmurzayeva et al. 2018; Holzapfel et al. 2013; Navarro et al. 2008). The oxides of chromium depend on their oxidation level with oxygen. Among the oxidation states, hexavalent chromium (VI) has been reported to have carcinogenetic effects and is toxic (Dayan and Paine 2001; Regan et al. 2019; Valko et al. 2006; Zhang et al. 2019). The risk of cancer due to chromate dust was firstly reported in 1890 for the people working in the chromate dye industry (Becker 1999; Langård 1994; Langrrd 1990). The chromium VI is toxic due to its oxidative properties, and if present in the human body, it can damage the liver, kidneys and blood cells leading to liver and renal failures (Dayan and Paine 2001).

The nickel is also one of the trace elements found in the human body (Sharma et al. 2018). Its existence in the human body was firstly discovered in 1970s (Ragsdale 2008). The nickel in human blood is bound to albumin fraction. Nickel is also found in urease which is an enzyme and helps in hydrolysis of urea (Nielsen et al. 1994; Wezynfeld et al. 2015). Almost 90% of the nickel is eliminated from the human body through urine (Rezuke et al. 1987; Tanaka et al. 2019). The deficiency of nickel has been associated with many effects including decreased ratio of leg bones and suppressed enzyme activities in the liver, kidney and heart leading to degeneration of skeletal and cardiac muscles in animals and human being (Szilagyi et al. 1991; Zambelli and Ciurli 2013). The nickel has also been reported to be toxic in increased amounts. Its toxicity was firstly reported in piercing of an ear. It leads to red skin with itching due to contact-allergy related–dermatitis (Boonchai et al. 2015; Santucci et al. 1989). The nickel is distinguished as one of the most allergic materials by the American Contact Dermatitis Society, and its quantity in products that come in direct contact with skin is controlled by the EU (Chen and Thouas 2015). The amount of nickel and its compounds inhaled in a year has been estimated to be 0.2 µg/m3 in the US (Kawamoto et al. 2011). The inhalation of excessive amounts of nickel has been associated with many respiratory diseases including sinusitis, chronic rhinitis, acute pneumonitis and cancer of lungs and nasal cavities (Chen and Thouas 2015). The nickel is also reported to be toxic to bone cells, but their carcinogenic effect is less than that of vanadium or cobalt (Yamamoto et al. 1998).

Combining the advantages of stable austenitic structure, low cost, ease of manufacturing and acceptable biocompatibility, stainless steel stays a widespread biomaterial for implant manufacturing and medical device applications. The material degradation due to inferior corrosion resistance, stress corrosion cracking, galvanic corrosion and corrosion fatigue in the human body limits this material in long-term applications. However, this drawback can be improved by alloying with certain additives that not only enhance their corrosion resistance but also improve their suitability as a biomaterial. Their mechanical and physical properties can be controlled by optimizing the processing parameters for improved performance.

3.1.2 Cobalt-based alloys

These materials find their applications in several fields. The cobalt molybdenum-based alloys were firstly used in aerospace by Haynes and were named as a satellite in aircraft engines (Chen and Thouas 2015; Manam et al. 2017). This newly developed material at that time showed better corrosion resistance and higher strength even at high temperatures as compared to other alloy systems of its class.

The cobalt-based alloys were firstly introduced in the medical field in 1930s and are widely used in implant manufacturing (Pramanik et al. 2005). The cobalt chromium molybdenum (CoCrMo) alloy applications in the medical field can be traced back to 1940s when it was firstly used as a cast or dental alloy implant (Davis 2003). Since then, it is widely used in dental and orthopaedic applications. The corrosion resistance and mechanical properties of cobalt chromium alloy systems are far better than those of stainless steels. By modifying the compositions of the constitutional alloy elements, several alloys have been developed as shown in Table 7.

Table 7:

Cobalt-based alloys used for implantation (Davis 2003; McGregor et al. 2000).

ASTM Alloy composition Manufacturing Application
F90-97 Co–20Cr–15W–10Ni Wrought Short-term implant
F563-95 Co–Ni–Cr–Mo–W–Fe Wrought Short-term implant
F799-99 Co–28Cr–6Mo Forged Permanent implant
F75-98 Co–28Cr–6Mo Cast Permanent implant
F562-95 Co–35Ni–20Cr–10Mo Wrought Permanent implant
F1537-94 Co–28Cr–6Mo Wrought Permanent implant
F1058-97 Co–Cr–Ni–Mo–Fe Wrought Permanent implant
F961-96 Co–35Ni–20Cr–10Mo Forged Permanent implant

The corrosion resistance of cobalt-based alloys is greater as compared to other materials of its class, and they exhibit excellent corrosion resistance in chloride-bearing environments (Alvarado et al. 2003; Navarro et al. 2008). The higher corrosion resistance of this alloy can be attributed to the presence of chromium in higher contents. The chromium can develop a passive oxide layer of Cr2O3 in human physiological conditions that helps in retention of implant and other medical devices for long time duration (Öztürk et al. 2006; Ramsden et al. 2007). The role of chromium and other alloying elements of this alloy has been discussed in Table 8.

Table 8:

Role of alloying elements in cobalt-based alloys (Chen and Thouas 2015).

Element Effect on mechanical properties Effect on corrosion resistance
Cr Increased wear resistance Increased corrosion resistance
Ni Solid solution strengthening Increased corrosion resistance
Mo Solid solution strengthening Increased corrosion resistance
W Solid solution strengthening Decreased corrosion resistance

The addition of tungsten in this alloy system helps in enhanced solid solution strengthening, whereas, on the other hand, decreases the corrosion resistance and corrosion fatigue strength. The tungsten-containing alloy systems find their applications in short-term implantation. These alloy systems are also prone to the leaching of toxic nickel ion release from the implant material, thus limiting its usage in permanent implant applications (Chen and Thouas 2015). The in vitro cytotoxicity assessment of CoCrMo alloy showed that it is less toxic than pure cobalt or nickel. The biocompatibility was found better due to increased corrosion resistance. In 1960s, the CoCrMo alloy was successfully used in total hip replacements. Later, the surface of CoCrMo hard-on-hard bearings was improved using surface polishing techniques. Although, the mechanical properties were improved but the implants showed wearing debris for patients with this system for usage in long term. Recently, adverse tissue reactions, potential teratogenic effects and serum metal ions levels are the major concerns of this alloy system (Yan et al. 2007; Zhang and Liu 2016). The harmful tissue reaction occurring due to corrosion at the femoral neck–body junction made up of cobalt–chromium alloy was investigated in patients with total hip arthroplasty. The magnetic resonance imaging (MRI) indicated abnormal results after metal artefact reduction sequence (MARS) and serum metal ions study. The MRI and MARS studies revealed adverse tissue reactions. The hips showed surrounding tissue damage and large soft tissue masses with noticeable corrosion at the neck–body junction. The surface of the junction was damaged consisting of black debris and fretting corrosion (Cooper et al. 2013). The retrieved modular femoral neck has been shown in Figure 14.

Figure 14: 
							Posterior (left) and medial (right) images of modular femoral neck (Cooper et al. 2013).
Figure 14:

Posterior (left) and medial (right) images of modular femoral neck (Cooper et al. 2013).

The cobalt-based alloys use cobalt as the matrix element, whereas chromium, nickel, molybdenum and tungsten are used as the alloying elements. The cobalt is a constituent of vitamin B12 and is one of the vital trace elements present in human red blood cells (Kennedy et al. 1995). However, high exposure of this element can cause harmful effects on the human body (Tower 2010, 2012). The toxicity of this material has been reported to be the cause of lung diseases when exposed at higher levels (Armstead et al. 2017). The leaching of this element from implants has been reported to be the cause of hypersensitivity reaction leading to tissue damage in the prosthesis vicinity (Gessner et al. 2019). The cobalt toxicity has been reported to be associated with severe headaches, decline in cognitive function, anorexia, dyspnoea, painful cramping and muscle fatigue (Mao et al. 2011).

The molybdenum is also an important trace element in human body enzymes. This element, however, is less toxic as compared to many of other elements. Its exposure on the human body does not represent a hazard in small concentrations (Turnlund 2002). However, this material can be toxic for people who are exposed to prolonged exposure as in metal working industries or mining (Barceloux and Barceloux 1999). The continual exposure to this element can cause joint pains, headaches and fatigue (Liber et al. 2011). The tungsten is chemically identical to molybdenum. Its effects on the human body are very limitedly reported (Smart et al. 2009). This element, however, is noncytotoxic; it is reported to be cautious when dealing with this element (Witten et al. 2012).

The cobalt-based alloys are expensive, limiting their percentage as compared to stainless steels in the medical market, especially in implant usage (Kamath et al. 2011). The limitations and drawbacks of this material include leaching of metal ions and stress shielding effects (Alvarado et al. 2003; Ramsden et al. 2007). They are associated with release of toxic metal ions of cobalt, chromium and nickel in the human body, thereby initiating inflammations in the body and causing allergic reactions. The wear debris, stress shielding and deterioration of implant material within the human body lead to implant failure (Chen and Thouas 2015). Although they have certain limitations and are much expensive, they are still the mostly used biomaterials for joint bearing systems.

3.1.3 Titanium and titanium-based alloys

Pure titanium is a low-density element that has the potential of being strengthened when alloyed with other elements. It undergoes phase transformation from Hexagonal closed pack (HCP) to Body centred cubic (BCC) crystal structure at around 885°C. Therefore, it must be alloyed with other elements to be used in the medical field (Chen and Thouas 2015).

The titanium and its alloys are widely utilized in aerospace, chemical and medical field since mid-1940s (Ratner et al. 2006). Owing to their bioinertness, light weight and unique mechanical properties, the scientists established titanium alloys for their potential use in the medical field (Arifin et al. 2014; Ferraris and Spriano 2016). The application of titanium alloy “Ti–6Al–4V” for medical usage was firstly reported in 1954. This alloy has been associated with excellent biocompatibility, enhanced corrosion resistance, superior plasticity and toughness with better formability (Hamidi et al. 2017). The modification of Ti–6Al–4V has resulted in several derived formulations of this alloy. These include Ti–6Al–7Nb and Ti–6Al–4V ELI in which certain constitutional elements are changed to enhance the mechanical properties of this alloy. These alloy systems find numeral applications in a wide range of medical fields (Frosch and Stürmer 2006; Liu et al. 2016).

Among available biomaterials, titanium and its alloys find their suitability in the implant manufacturing owing to their biocompatibility, corrosion resistance, thermomechanical processing and strength (Bauer et al. 2013; Mendes et al. 2016). The increased usage of titanium and its alloys owes to their improved in vivo and in vitro corrosion resistance and excellent fatigue resistance. The enhanced corrosion resistance is due to the formation of stable and dense passive oxide layer of TiO2. This passive layer is spontaneously rebuilt as soon as it gets depleted. This leads to better corrosion resistance among the other materials of its class (Saud et al. 2016; Siraparapu et al. 2013).

Titanium element is not found in trace elements of the human body. It is nontoxic even in large amounts. It has been reported that it does not play any biological role in the human body (Chen and Thouas 2015; Kang and Fang 2018a,b). It does not get absorbed or digested by the human body and is excreted as such even if it has been ingested by the human body on a daily basis (Yaghoubi et al. 2000). The implants made of titanium generally develop good physical connection with the human bone; however, osteogenic differentiation of mesenchymal stem cells is inhibited leading to genetic alterations in the tissues (Coen et al. 2003; Wang et al. 2003).

The vanadium present in Ti–6Al–4V is less associated with its biological role in the human body after titanium (Chen and Thouas 2015). It may have positive or negative cellular responses in human cells and tissues (Kumazawa et al. 2002). Vanadium can be toxic in its oxide form (Sanna et al. 2009; Trevino et al. 2019). The in vivo studies on animals have revealed that inhalation or oral exposures to vanadium leads to adverse effects on the liver, blood, respiratory system and other organs and may lead to carcinogenicity (Ress et al. 2003; Rhoads et al. 2010). A recent case has been reported on the possible linkage of implant failure with vanadium leaching (Moretti et al. 2012).

The aluminium present in titanium alloys has little known function in the human body. The toxicity of aluminium involving neurological problems has increased in the recent past (Verstraeten et al. 2008). A public awareness of its toxicity by domestic use of aluminium cookware in the recent years has increased (Gao et al. 2019; Gui et al. 2015; Verstraeten et al. 2008). Aluminium has been reported to be the cause of serious diseases. These include osteopenia which is a reduced skeletal mineralization observed in infants (Banks and Kastin 1989; Davitoiu et al. 2018). There are reports on neurotoxicity, digestive disorders, kidney diseases, dermatitis and altered blood–brain barrier function due to aluminium toxicity (Mardini et al. 2014; Yokel 2000; Zhou et al. 2018). Recently, reports suggest that aluminium toxicity is also associated with breast cancer cells indicating that excessive exposure to this element may lead to breast cancer and Alzheimer disease (Darbre 2006; Niinomi et al. 2012).

The biocompatibility and corrosion resistance of titanium alloys is superior to other biomaterials (Niinomi and Boehlert 2015). However, this material is associated with poor wear resistance in articulating situation and adverse tissue reactions from implant failures in the human body (Sumita et al. 2003). A recent failure of hip joint implant has revealed the unreliability of this material as shown in Figure 15. The premature fracture of the neck of the hip joint implant has raised questions on the durability of this material. The results of finite element analysis reveal that the poor bending performance of this alloy is responsible for premature fracture (El-Shiekh 2002).

Figure 15: 
							Titanium-made stem broken in total hip replacement (Chen and Thouas 2015).
Figure 15:

Titanium-made stem broken in total hip replacement (Chen and Thouas 2015).

A realistic titanium alloy with excellent wear resistance and fatigue strength has yet to be developed, and a mechanically reliable titanium alloy has yet to become a reality.

3.1.4 Other metals

To explore other metals with relatively good corrosion resistance, wear resistance, chemical stability and mechanical strength, nontraditional metals have been investigated (Jones et al. 2017). Zirconium is one of those materials that can be utilized in implant manufacturing. In an attempt, a zirconium implant surface was transformed into wear resistant ceramic by a thermal processing method (Good et al. 2003; Sheth et al. 2008). This material finds applications in knee and hip joint replacements. The major limitation of this material is its high cost of manufacturing that limits its usage in implant manufacturing (Jones et al. 2017). Tantalum is another material with enhanced corrosion resistance. This material finds applications in highly porous constructs (Williams and Chawla 2014). This material has good mechanical strength, thus making it an ideal material for joint fixation applications, bone void fillers, spine implants and trauma applications (Malizos et al. 2008; Pakos et al. 2015). Another alloy that finds applications in the medical field is nitinol which is also known as shape memory alloy. It is an alloy of nickel–titanium which possesses reversible martensitic phase transformation. The shape memory effect is the ability of a material to return to its original shape upon heating. This property enables its plastic deformation at low temperatures, and at higher temperatures, it gains back its original shape. This material finds applications in rods, staples and wires (Ong et al. 2014).

4 Limitations of current metallic biomaterials

The metallic biomaterials used in dental and other implants have certain limitations which restrict their usage in long-term implant applications. The limitations of some of the currently used metallic biomaterials have been highlighted below:

  • – The presence of Ni and Cr elements in stainless steel alloy proves to be toxic in long-term implantation (Keegan et al. 2007). The toxicity of Ni leads to dermatitis and other skin diseases.

  • – The leaching of Co and Cr elements in Co–Cr alloys has proved to contaminate the human body (Yamanaka et al. 2019).

  • – The existence of Co results in carcinogenic effects on the human body (McGregor et al. 2000).

  • – The titanium alloys that contain Al and V have found to cause diseases like neuropathy, osteomalacia and Alzheimer disease in long-term implant applications (Cordeiro et al. 2017). The accumulation of Al and V ions inside the human body can lead to severe health problems.

  • – The loosening of implants due to osteolysis has been associated with inflammatory reactions due to wear debris formation (Prakash 2005; Swiatkowska et al. 2019)

The currently used metallic biomaterials, their applications, advantages and disadvantages have been reviewed in Table 9.

Table 9:

Advantages and limitations of current metallic biomaterials.

Metallic biomaterial Principal applications Advantages Disadvantages
Stainless steels

316L stainless steel
Dental implants, stents, fracture fixation, surgical instruments High wear resistance, low cost, ease of manufacturing Allergy considerations with Ni, Co and Cr
Titanium and its alloys

Cp–Ti

Ti–Al–Nb

Ti–Al–V

Ti–Mo–Zr–Fe

Ti–Nb–Zr
Dental implants, fracture fixation, bone and joint replacement, pacemaker encapsulation Good corrosion resistance, low Young’s modulus, high biocompatibility Low density, toxic effects of Al, V and Ti in long-term applications, poor tribological properties
Co–Cr–Mo alloys

Co–Cr–Mo

Cr–Ni–Cr–Mo
Dental restorations, dental implants, bone replacements, heart valves High wear resistance Allergy considerations with Ni, Co and Cr
Others

Ni–Ti

Hg–Ag–Sn amalgam
Dental restorations In situ formability, easy in making desired shapes Susceptible to corrosion in oral environment, concerns related to toxicity of Hg

5 Critical analysis

The previous research on biomaterials with regards to corrosion resistance, biocompatibility, degradation and biomechanical characteristics of the most commonly used materials has been discussed in the previous sections. Based on the literature, the important characteristics of currently used biomaterials as compared to stainless steel have been critically assessed in Table 10. The grades range from 5 = excellent score to 1 = poor score. It can be observed that stainless steel underweights the current biomedical materials in terms of corrosion resistance, biocompatibility and bioactivity.

Table 10:

Critical analysis on characteristics of biomaterials (Fathi et al. 2003; Geetha et al. 2009; Niinomi 2008).

Characteristics Stainless steels Co-based alloys Ti-based alloys
Corrosion resistance 2 3 4
Wear resistance 2 2 1
Biocompatibility 1 2 2
Bioactivity 1 1 1

It can be observed that stainless steel underweights the current biomedical materials in terms of corrosion resistance, biocompatibility and bioactivity. Titanium and its alloys show better corrosion resistance, whereas the wear resistance of cobalt-based alloys is better than stainless steel and titanium-based alloys. The biocompatibility of titanium- and cobalt-based alloys can be considered to be equally rated as per cited in the literature.

Despite several efforts on improving the material properties, the premature implant failure and leaching of metal ions from the base material remains unsolved. Some recent articles on implant failure were critically analysed. The articles were critically analysed to determine the cause of failure of implants and implant materials. The analysis indicated that the implant failures were due to several factors which include poor material quality, inferior material surface finishing, crack initiation from implant fabrication or coating method, high wear and corrosion rate of the implant material.

The recently failed implants and implant materials lead to the conclusion that optimizing the processing parameters of the biomaterials has a great potential in improving the material properties. Table 11 presents some critically assessed implants that failed at early stages of implantation.

Table 11:

Critical analysis on premature failed orthopaedic and dental implants.

Author (year) Material (implant type) Expected causes / effects of implant failure Implant duration
Inna Jason et al. (2018) 316L stainless steel (PHILOS plate) − Crack propagation due to inclusions

− Multi-site corrosion damage

− Corrosion fatigue

− Loosening of the device
18 months
Geravis, et al. (2016) 316L stainless steel (femoral bone) − High failure cycles (106 cycles)

− Unexpected fall of the patient

− Corrosion fatigue

− Loosening of the device
< 24 months
Varadharajan et al. (2016) Co-Cr alloy (hemi-toe implant) − Device loosening

− Coating spalled

− Debris deposition

− Pits and scratches in the middle region
Patient details not available
Goswami et al. (2016) Ti alloy (ankle arthrodesis nail) − Pre-crack and failure

− Wear in some areas of coating and cap threads

− Plastic deformation of threads
< 100 cycles
Stronach et al. (2016) No evidence of material (hip stem) − Fretting corrosion

− Crevice corrosion

− Fatigue failure
72 months
Thapa et al. (2015) 316L stainless steel (locking compression plate) − Corrosion fatigue

− Fatigue crack

− Crack propagation (cyclic loading)
2035 cycles
Guerra-Fuentes at al. (2015) 316L stainless steel (femoral bone) − Bone callus formation

− Fretting wear of fixation screws

− Fatigue failure

− Plate implant fractured
4 months
Hernandez-Rodriguez et al. (2015) Ti-6Al-4V (dental implant) − Bone re-sorption

− Rough surface finish in the screw

− Crack and fractured
6 months
Williams Jason et al. (2014) Ti-6Al-4V (hip implant) − Crevice corrosion

− Fretting damage

− Fatigue crack
36 months
Macromini et al. (2014) 316L stainless steel (femoral bone) − Poor material quality

− High phosphorus content

− Segregation at grain boundaries

− Crack propagation (cyclic loading)

− Loss of ductility due to cold work
1st failed at 4 months, sent back to manufacturer, 2nd failed at 6 months

6 Conclusion

In this paper, a comprehensive review of the currently used biomaterials such as stainless steel, cobalt chromium and titanium alloys has been presented in detail. The properties of the biomaterials including biocompatibility, corrosion resistance, osseointegration, metal ion release, physical and mechanical properties have also been assessed in detail. The limitations of the currently used biomaterials with possible research gap have been included to identify the research gap. In the last, a critical analysis of currently failed biomaterials has been done to highlight the possible causes of implant failures. Poor material quality coupled with inferior corrosion resistance and defects initiated by implant manufacturing techniques was the major causes of implant premature failure.


Corresponding author: Sadaqat Ali, Mechanical Engineering Department, Universiti Teknologi PETRONAS (UTP), Block 17, Seri Iskandar, 32610, Malaysia; and School of Mechanical and Manufacturing Engineering, National University of Sciences and Technology (NUST), H-12, Islamabad, Pakistan, E-mail:

Funding source: YUTP-FRG Project Cost Centre

About the authors

Sadaqat Ali

Dr. Sadaqat Ali obtained his BSc in mechanical engineering from UET, Peshawar, Pakistan, in 2007, his MSc from Malardalens University, Sweden, in 2011 and his PhD in mechanical engineering from Universiti Teknologi PETRONAS, Malaysia, in 2020. His current research includes advanced materials development via additive manufacturing and powder metallurgy for aerospace and biomedical applications. He is currently working as an assistant professor at SMME, National University of Sciences & Technology, Islamabad, Pakistan.

Ahmad Majdi Abdul Rani

Dr. Ahmad Majdi Abdul Rani is currently an associate professor in Universiti Teknologi Petronas, Malaysia. He completed his PhD in mechanical and manufacturing from Loughborough University, UK. He obtained his MSc in industrial engineering and his BSc in manufacturing engineering from Northern Illinois University, USA. His area of expertise is in advanced manufacturing of biomedical implants, reverse engineering, CAD/CAM and PM-EDM. He has graduated nine PhD and six MSc candidates and has published numerous articles in high index journals.

Zeeshan Baig

Dr. Zeeshan Baig received his MSc engineering degree (metallurgy and materials) from U.E.T, Pakistan, in 2006. He received his PhD in mechanical engineering from Universiti Teknologi PETRONAS in 2019. His current research interests include advanced materials development via additive manufacturing for aerospace, automotive and biomedical applications. He authors various international scientific publications, including articles in journals and conference proceedings.

Ghulam Hussain

Dr. Ghulam Hussain is currently working as an associate professor at GIK Institute of Engineering Sciences & Technology, Pakistan. His research interests include advanced materials, advanced manufacturing, corrosion and sustainability. He is the author of numerous review and research articles. He is actively involved in research with renowned international universities. He has been listed as “National Productive Scientist” and selected as a Foreign Expert on Manufacturing in China and a Foreign Research Member of King Abdul–Aziz University.

Krishnan Subramaniam

Krishnan Subramaniam studied in Ipoh, Perak. He has post-graduate degrees (MSc and MEng) in mechanical engineering from Universiti Teknologi PETRONAS (UTP) and University Tunku Abdul Rahman (UTAR), Malaysia. He joined as a senior lecturer at Manipal International University in 2016 and obtained his PhD degree from Universiti Teknologi PETRONAS in 2017. He has proposed a new rehabilitation model for human beings using smart materials and done a lot of clinical studies in hospitals.

  1. Author contribution: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: The authors would like to acknowledge YUTP-FRG project cost centre 015LC0-040 and School of Mechanical and Manufacturing Engineering (SMME) and the National University of Sciences & Technology, Pakistan, for providing the resources and funding for this research work.

  3. Conflicts of interest: The authors declare no conflicts of interest regarding this article.

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Received: 2020-01-01
Accepted: 2020-06-11
Published Online: 2020-08-27
Published in Print: 2020-10-25

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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