Total joint replacement in orthopedic surgery can be achieved by excision, interposition, and replacement arthroplasty. This article details the most common materials used in total replacement synovial joints, such as metals, ceramics, and ultrahigh molecular weight polyethylene (UHMWPE). The principal physical properties and tribological characteristics of these materials are summarized. The article discusses the pin-on-disk experiments and pin-on-plate experiments for determining friction and wear characteristics. It details the use of various types of joint simulators, such as hip joint simulators and knee joint simulators, to evaluate the performance of engineering tribological components in machine simulators. The article describes in vivo assessment of total joint replacement performance.

This article outlines some of the selection criteria for choosing an implant material for biomedical devices in orthopedic, dental, soft-tissue, and cardiovascular applications. It details the development of implants based on materials, such as metallic implants, ceramic implants, and polymeric implants. The article discusses the specific problems associated with implant manufacturing processes and the consequent compromises in properties of functionally graded implants. It describes the manufacturing of the functionally-graded hip implant by using the LENS process. It reviews the four different types of tissue responses to the biomaterial. The article discusses the testing of implant failure, such as in vitro and in vivo assessment of tissue compatibility.

This article provides a summary of biocompatibility or biological response of metals, ceramics, and polymers used in medical implant, along with their clinical issues. The polymers include ultrahigh-molecular-weight polyethylene, nonresorbable polymer, and resorbable polymers.

The biocompatibility of a material relates to its immunological response, toxicity profile, and ability to integrate with surrounding tissue without undesirable local or systemic effects on a patient. This article underscores the transformation of the medical device design ecosystem engaged as an integral part of the device ecosystem. It discusses the various applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes the four major categories of biomaterials, such as metals, polymers, glass and ceramics, and composites. A discussion on natural materials, nanomaterials, and stem cells is also provided. The article concludes with information on examples of biomaterials applications, including endovascular devices, knee implants, and neurostimulation.

The interaction of an implant with the human body environment may result in degradation of the implant, called corrosion. This article discusses the corrosion testing of metallic implants and implant materials. The corrosion environments for medical implants are the extracellular human body fluids, very complex solutions containing electrolytes and nonelectrolytes, inorganic and organic constituents, and gases. The article describes the fundamentals of electrochemical corrosion testing and provides a brief discussion on various types of corrosion tests. It illustrates corrosion current density determination by Tafel extrapolation, potentiodynamic measurement of the polarization resistance, electrochemical impedance measurement, and potentiostatic deaeration. Tests combining corrosion and mechanical forces, such as fretting corrosion tests, environment-assisted cracking tests, and ion-leaching tests are also discussed.

Stainless steels are used for medical implants and surgical tools due to the excellent combination of properties, such as cost, strength, corrosion resistance, and ease of cleaning. This article describes the classifications of stainless steels, such as austenitic stainless steels, martensitic stainless steels, ferritic stainless steels, precipitation-hardening stainless steels, and duplex stainless steels. It contains a table lists common medical device applications for stainless steels. The article discusses the physical metallurgy, and physical and mechanical properties of the stainless steels. Medical device considerations for stainless steels, such as fatigue strength, corrosion resistance, and passivation techniques, are reviewed. The article describes the process features of the implant-grade stainless steels, including type 316L, type 316LVM, nitrogen-strengthened, ASTM F1314, ASTM F1586, ASTM F2229, and ASTM F2581 stainless steels.

Titanium and its alloys have been used extensively in a wide variety of implant applications, such as artificial heart pumps, pacemaker cases, heart valve parts, and load-bearing bone or hip joint replacements or bone splints. This article discusses the properties of titanium and its alloys and presents titanium-base biomaterials in a table. Titanium components are produced in wrought, cast, and powder metallurgy (PM) form. The article describes forging, casting, and heat treating of titanium alloys for producing titanium components. Typical mechanical properties of titanium biomedical implant alloys are listed in a tabular form. The article presents an overview of surface-modification methods for titanium and its alloys implants. It concludes with a section on biocompatibility and in vivo corrosion of titanium alloys.

This article discusses the mechanisms of metal and alloy biocompatibility. It provides information on early testing and experience with metals in medical device applications. The article describes the response to severe corrosion of implant and particulate materials. It provides a description of metal binding and its effects on metabolic processes. The hypersensitive responses to metal ions are also reviewed. The article concludes with a discussion on possible cancer-causing effects of metallic biomaterials.

Polymers offer a wide range of choices for medical applications because of their versatility in properties and processing. This article provides an overview of polymeric materials and the characteristics that make them a unique class of materials. It describes the ways to classify polymers, including the polymerization method, how the material deforms, or molecular origin or stability. The article contains tables that list common medical polymers used in medical devices. It describes the medical polymer selection criteria and regulatory aspects of materials selection failure analysis and prevention. Failure analysis and prevention processes to determine the root cause of failures that arise at different stages of the product life cycle are reviewed. The article describes the mechanisms of plastic product failure analysis. It discusses the trends in the use of medical polymers, such as high-performance polymers for implants, tissue engineering, and bioresorbable polymers.

This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.

This article contains a table that lists ISO standards for the biological evaluation of medical devices.

This article tabulates materials that are known to have been used in orthopaedic and/or cardiovascular medical devices. The materials are grouped as metals, ceramics and glasses, and synthetic polymers in order. These tables were compiled from the Medical Materials Database which is a product of ASM International and Granta Design available by license online and as an in-house version. The material usage was gleaned from over 24,000 U.S. Food and Drug Administration (USFDA), Center for Devices and Radiological Health, Premarket notifications (510k), and USFDA Premarket Approvals, and other device records that are a part of this database. The database includes other material categories as well. The usage of materials in predicate devices is an efficient tool in the material selection process aiming for regulatory approval.

Microjoining methods are commonly used to fabricate medical components and devices. This article describes key challenges involved during microjoining of medical device components. The primary mechanisms used in microjoining for medical device applications include microresistance spot welding (MRSW) and laser welding. The article illustrates the fundamental principles involved in MRSW and laser welding. Most multicomponent medical devices implement microjoining techniques to join various forms of materials and geometries. The article presents examples of various microjoining methods used in medical device applications, including pacemaker and nitinol microscopic forceps.

This article provides the background of biological evaluation of medical devices. It discusses what the ISO 10993 standards require for polymeric biomaterials and presents examples of what qualitative and quantitative tests can be used to satisfy the requirements. The article describes infrared (IR) analysis and thermal analyses that are used extensively to fingerprint polymeric materials and should be a part of all polymeric biomaterials characterization programs. It also provides a discussion on the chemical characterization and risk assessment of extracts. Background information on risk assessments of extracts is also included. The four basic steps that are commonly used in the risk assessment process are discussed. These steps include hazard identification, dose-response assessment, and exposure assessment, and risk characterization.

This article provides an overview of curing techniques, adhesive chemistries, surface preparation, adhesive selection, and medical applications for adhesives. The curing techniques are classified into moisture, irradiation, heat, and anaerobic. The article highlights the common types of curable adhesives used for medical device assembly, including acrylics, cyanoacrylates, epoxies, urethanes, and silicones. Other forms of adhesives, such as hot melts, bioadhesives, and pressure-sensitive adhesives, are also discussed. Adhesives are used for medical device assembly, hard-tissue attachment in the fields of orthopedics and dentistry, and soft-tissue attachment such as wound closure. The typical characteristics and applications of biocompatible medical device adhesives are listed in a table. The article concludes with a section on selection of materials for medical adhesives.

This article addresses the biologic aspects of implant debris both locally and systemically. It discusses the particulate debris, such as stainless steel, cobalt alloy, and titanium alloy, and soluble debris obtained due to wear from all orthopedic implants. Implant debris is known to cause local inflammation, local osteolysis, and, in some cases, local and systemic hypersensitivity. The article describes debris-induced local effects, particle-induced proinflammatory responses, and debris-induced systemic effects. It concludes with a discussion on the four systemic effects of implant debris, namely, neuoropathic effects, hypersensitivity effects, carcinogenictiy, and general toxicity.

Ceramics are used widely in a number of different clinical applications in the human body. This article provides a brief history of the bioceramics field and information on the classification of the different types of bioceramics. These include bioinert ceramics, bioactive ceramics, and bioresorbable ceramics. The article describes the third-generation bioceramics, classified by Hench and Polak, such as silicate-substituted hydroxyapatite and bone morphogenic protein-carrying calcium phosphate coatings. It reviews several examination methods that are used to test the biocompatibility of ceramics, namely, biosafety testing, biofunctionality testing, bioactivity testing, and bioresorbability testing.

This article focuses on the use of noble and precious metals for biomedical applications. The noble metals include gold, platinum, palladium, ruthenium, rhodium, iridium, and osmium. The physical and mechanical properties of the noble and precious metals are presented in tables. A brief discussion on the ancient history of noble and precious metal use in dentistry is provided. The article discusses the use of direct gold dental filling materials, direct silver dental filling materials, traditional amalgam alloys, high-copper amalgam alloys, and gallium alloys in biomedical applications. Modern stents were developed as a result of balloon catheterization research. The article describes gold coatings and iridium oxide coatings for stents.

Structural applications for advanced ceramics include mineral processing equipment, machine tools, wear components, heat exchangers, automotive products, aerospace components, and medical products. This article begins with an overview of the wear-resistant applications and the parameters affecting wear of ceramics, namely, hardness, thermal conductivity, fracture toughness, and corrosion resistance. The next part of the article addresses temperature-resistant applications of advanced ceramics. Specific applications of ceramic materials addressed include cutting tools, pump and valve components, rolling elements and bearings, paper and wire manufacturing, biomedical implants, heat exchangers, adiabatic diesel engines, advanced gas turbines, and aerospace applications.

Physically, tantalum is a dark, blue-gray, lusterless metal that exists in two crystalline forms: an alpha-phase with a body-centered cubic structure, and a brittle beta-phase with a tetragonal orientation. This article tabulates the physical and material properties of tantalum. It discusses the use of tantalum in medical electronics and the advantage of tantalum over stainless steel. The article describes the manufacturing and medical applications of tantalum foam.