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: metals, ceramics, and ultrahigh molecular weight polyethylene (UHMWPE). The principal physical properties and tribological characteristics of these materials are summarized. The article discusses pin-on-disk experiments and pin-on-plate experiments for determining friction and wear characteristics. It explains 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 concludes with a section on the in vivo assessment of total joint replacement performance.

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

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 discusses the classification of bioceramics. These include bioinert ceramics, bioactive ceramics, and bioresorbable ceramics. The article describes 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 used to test the biocompatibility of ceramics, namely, biosafety testing, biofunctionality testing, bioactivity testing, and bioresorbability testing.

This article discusses several aspects of biocompatibility of polymers, including the selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes the factors influencing the biological response of the polymer from a biocompatibility perspective. These include raw materials, the manufacturing process, cleaning and sterilization processes, and biodegradation and biostability. The article reviews the general testing methods of polymers, such as chemical, mechanical and thermal. It concludes with a section on the guidance, provided by the regulatory authorities, on the biocompatibility testing of polymers and polymer-containing devices that can aid in selecting the right analysis.

Inkjet printing is extremely precise in terms of the ejected microdroplets (picoliter volume), contributing an unparalleled lateral resolution. Additionally, the benefits of high-speed deposition, contactless ink delivery, and the use of a range of ink materials endorse this technique as suitable for high-throughput 3D manufacturing. This article provides an overview of inkjet 3D printing (also referred to as 3D inkjetting). It then highlights the major components and accessories used in commercial and laboratory-based 3D inkjet printers. Next, the article describes the process physics of the transient phenomena involved in both binder-jetting- and direct-inkjetting-based 3D printing. It then discusses the scope and advantages of 3D inkjetting in the manufacturing of metallic, ceramic, and polymer-based biomaterials. The article also discusses several approaches and methodologies to examine the in vitro cytocompatibility and in vivo biocompatibility of both binder-jetted and direct-inkjetted scaffolds for biomedical applications. Finally, it discusses the challenges and troubleshooting methodologies in 3D inkjetting of biomaterials.

Additive manufacturing, or three-dimensional printing technologies, for biomedical applications is rather different from other engineering components, particularly for biomedical implants that are intended to be used within the human body. This article contains two sections: "Design and Manufacturing Considerations of 3D-Printed, Commercially Pure Titanium and Titanium Alloy-Based Orthopedic Implants" and "Device Testing Considerations Following FDA Guidance" for additive-manufactured medical devices. These are further subdivided into five major focus areas: materials; design, printing, printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility.

This article discusses some of the additive manufacturing (AM) based fabrication of alloys and their respective mechanical, electrochemical, and in vivo performance. Firstly, it briefly discusses the three AM techniques that are most commonly used in the fabrication of metallic biomedical-based devices: binder jetting, powder-bed fusion, and directed-energy deposition. The article then characterizes the electrochemical properties of additive-manufactured/processed cobalt-chromium alloys. This is followed by sections providing an evaluation of the biological response to CoCr alloys in terms of the material and 3D printing fabrication. Discussion on the biological response as a function of direct cellular activity on the surface of CoCr alloys in static conditions (in vitro), in dynamic physiological conditions (in vivo), and in computer-simulated conditions (in silico) are further discussed in detail. Finally, the article provides information on the qualification and certification of AM-processed medical devices.

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

This article describes mechanical/electrochemical phenomena related to in vivo degradation of metals used for biomedical applications. It discusses the properties and failure of these materials as they relate to stress-corrosion cracking (SCC) and corrosion fatigue (CF). The article presents the factors related to the use of surgical implants and their deterioration in the body environment, including biomedical aspects, chemical environment, and electrochemical fundamentals needed for characterizing CF and SCC. It provides a discussion on the use of metallic biomaterials in surgical implant applications, such as orthopedic, cardiovascular surgery, and dentistry. It addresses key issues related to the simulation of an in vivo environment, service conditions, and data interpretation. These include the frequency of dynamic loading, electrolyte chemistry, applicable loading modes, cracking mode superposition, and surface area effects. The article explains the fundamentals of CF and SCC, and presents the test findings from laboratory, in vivo, and retrieval studies.

This article provides a background to the biological evaluation of medical devices. It discusses what the ISO 10993 standards require for polymeric biomaterials and presents examples of qualitative and quantitative tests that can be used to satisfy these requirements. The article describes infrared (IR) and thermal analyses that are used extensively to fingerprint polymeric materials. It also presents 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 include hazard identification, dose-response assessment, and exposure assessment, and risk characterization.

This article describes the corrosion resistance and ion release from main transition metallic bearings used as medical devices. It discusses the main issues associated with the in vivo presence of ions and their biocompatibility during the exposure of patients to different aspects of ion toxicity. These include ion concentration and accumulation in organisms, reactive oxygen species and oxidative stress, and carcinogenicity stimulated by the corrosion process and toxic ions release.

This article provides information on biomedical aspects such as active biological responses and the chemical environment characterizing the internal physiological milieu, as well as electrochemical fundamentals needed for characterizing corrosion fatigue (CF) and stress-corrosion cracking (SCC). It discusses some of the mechanical and electrochemical phenomena related to the in vivo degradation of materials used for biomedical applications. These materials include stainless steels, cobalt and titanium-base alloy systems, and dental amalgam. The article addresses key issues related to the simulation of the in vivo environment, service conditions, and data interpretation. The factors influencing susceptibility to CF and SCC are reviewed. The article describes the testing methodology of CF and SCC. It also summarizes findings from laboratory testing, in vivo testing and retrieval studies related to CF and SCC.

This article provides an overview of additive manufacturing (AM) methods, the three-dimensional (3D)-AM-related market, and the medical additive manufactured applications. It focuses on the current scenario and future developments related to metal AM for medical applications. The discussion covers the benefits of using 3D-AM technology in the medical field, provides specific examples of medical devices fabricated by AM, reviews trends in metal implant development using AM, and presents future prospects for the development of novel high-performance medical devices via metal 3D-additive manufacturing.

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

Bioprinting has been advancing in the field of tissue engineering as the process for fabricating scaffolds, making use of additive manufacturing technologies. In situ bioprinting (also termed intraoperative bioprinting) is a promising solution to address the limitations of conventional bioprinting approaches. This article discusses the main approaches and technologies for in situ bioprinting. It provides a brief overview of the bioprinting pipeline, highlighting possible solutions to improve currently used approaches. Additionally, case studies of in situ bioprinting are provided and in situ bioprinting future perspectives are discussed.

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.

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.

The use of 3D bioprinting techniques has contributed to the development of novel cellular patterns and constructs in vitro, ex vivo, and even in vivo. There are three main bioprinting techniques: inkjet printing, extrusion printing (also known as bioextrusion), laser-induced forward transfer (LIFT) printing, which is also known as modified LIFT printing, matrix-assisted pulsed-laser evaporation direct write, and laser-based printing (laser-assisted bioprinting, or biological laser printing). This article provides an overview of the LIFT process, including the LIFT process introduction, different implementations, jetting dynamics, printability phase diagrams, and printing process simulations. Additionally, materials involved during LIFT are introduced in terms of bioink materials and energy-absorbing layer materials. Also, the printing of single cells and 2D and 3D constructs is introduced, showcasing the current state of the art with the ultimate goal for tissue- and organ-printing applications.

Hydroxyapatite (HA) is one of the most popular materials in tissue scaffold engineering due to its similarity to the nature of human bone; it accounts for more than half of the total weight of the latter. Selective laser sintering (SLS) is an additive manufacturing method that is used in producing tissue engineering parts from HA feedstocks. This article provides a brief overview of the process itself, along with a detailed review of HA-based tissue engineering applications using SLS. Discussion on the various polymer composites is presented. A detailed overview of selected publications on HA-based SLS studies is listed, which provides insight regarding technical aspects of processing HA powder feedstocks.

This article reviews the concepts considered important for an understanding of the processes used for preparing cobalt-chromium alloy implants, the microstructures resulting from this processing, and the resulting material properties. The review includes solidification of alloys, diffusionless (martensitic) phase transformation as occurs with face-centered cubic to hexagonal close-packed transformation in cobalt-chromium alloys, and stacking faults and twins and their role in this transformation. It also discusses the strengthening mechanisms that are responsible for the mechanical properties of cast and wrought cobalt alloys. The article contains tables that list the commonly used cobalt alloys and their biomedical applications and chemical compositions. It discusses the mechanical and corrosion properties of cobalt alloys, and provides a description of the microstructure of cobalt alloys.