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in Failure Analysis of Medical Devices
> Analysis and Prevention of Component and Equipment Failures
Published: 30 August 2021
Fig. 20 Optical microscopy image of fracture surfaces of a knee implant hinge post, which fractured in vivo
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Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005660
EISBN: 978-1-62708-198-6
.... A discussion on natural materials, nanomaterials, and stem cells is also provided. The article concludes with examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation. biocompatibility biomaterials cardiac pacemakers cardiovascular applications ceramics...
Abstract
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 applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes 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 examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation.
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Published: 01 December 2004
Fig. 1 Implant devices. (a) The components of a prosthetic total hip implant system. (b) The components for a prosthetic total knee implant system. (c) Examples of fracture fixation components such as plates, screws, cables, and rods
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Series: ASM Handbook
Volume: 18
Publisher: ASM International
Published: 31 December 2017
DOI: 10.31399/asm.hb.v18.a0006404
EISBN: 978-1-62708-192-4
..., namely, total disc replacement in the spine, dental implants, and temporomandibular joint. It describes the various testing methods for characterizing the implant materials used in hip, knee, spine, and dental applications. The article also describes the typical standards used for testing wear behavior...
Abstract
The human internal environment plays a vital role in the friction and wear of implants and prosthetic devices. This article describes the tribological/wear behavior of implants. It discusses the classification of active tribological pairs, namely, amphiarthosis joints and diarthosis joints. The article details the classification of total knee replacement, depending on the type of mechanical stability, including nonconstrained knee replacement, semiconstrained knee replacement, and constrained knee replacement. It also discusses the classifications of passive tribological pairs, namely, total disc replacement in the spine, dental implants, and temporomandibular joint. It describes the various testing methods for characterizing the implant materials used in hip, knee, spine, and dental applications. The article also describes the typical standards used for testing wear behavior of tribological pairs, namely, hip-wear simulation standards, knee-wear simulation standards, and spinal disc-wear simulation standards.
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Published: 01 January 2005
Fig. 28 Simulated tibial knee forging implant after trimming in between the blocker and finisher operations
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Published: 01 December 2008
Fig. 17 Titanium knee and hip implant prostheses manufactured by the investment casting process
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in Titanium and Titanium Alloy Castings
> Properties and Selection: Nonferrous Alloys and Special-Purpose Materials
Published: 01 January 1990
Fig. 18 Titanium surgical knee and hip implant prostheses manufactured by the investment casting process
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Published: 01 December 1998
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Published: 01 November 2010
Fig. 28 Simulated tibial knee forging implant after trimming in between the blocker and finisher operations
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Published: 30 June 2023
Fig. 4 (a) Graphic image of a conventional implant currently used in total knee arthroplasty, composed of metal femoral and tibial components and an ultra-high-molecular-weight polyethylene (UHMWPE) component. Adapted from Ref 89 . (b) Graphic showing a prototype of a tibial stem manufactured
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Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005656
EISBN: 978-1-62708-198-6
... the concerns regarding the longevity of cemented orthopaedic implants. Moreover, these technologies have been expanded for use in revision total hip/knee replacement components, total shoulder replacement components, and spine implants. However, traditional porous coatings possess a number of shortcomings...
Abstract
Porous coatings are used in the field of joint replacement, particularly in cementless total hip/knee arthroplasty. This article reviews the offerings and biomaterial properties in orthopedic surgery for the contemporary class of highly porous metals. It describes the traditional porous metals/coatings having an open-cell structure, high porosity, and a microstructure resembling that of the cancellous bone. The traditional porous metal/coating includes fiber-metal mesh, cobalt-chromium (CoCr) beads, cancellous-structured titanium, and plasma spray. The article discusses other porous metals/coatings that have been developed due to the limitations of traditional porous metals for numerous open-cell-structured metals, such as titanium-base foams and trabecular metals.
Series: ASM Handbook
Volume: 9
Publisher: ASM International
Published: 01 December 2004
DOI: 10.31399/asm.hb.v09.a0003792
EISBN: 978-1-62708-177-1
... knee implant system that includes a tibial component, which is an upper extension of the tibia (shin bone) with a polymeric (UHMWPE) cushion, a femoral component that curves around the end of the femur (thigh bone), and a patellar component that replaces the kneecap. Bone structures can also be damaged...
Abstract
Metallography plays a significant role in the quality control of metals and alloys used in the manufacture of implantable surgical devices. This article provides information and data on metallographic techniques along with images showing the microstructure of biomedical orthopedic alloys, including stainless steels, cobalt-base alloys, titanium and titanium alloys, porous coatings, and emerging materials.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005659
EISBN: 978-1-62708-198-6
... is that the risk of not complying with these ideals is outweighed by the benefits to the patient; examples of this are total hip and knee implants. This means that the risk of not complying with these ideals is considered less than the benefits to the patient. The implantation of a total hip or knee device...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005666
EISBN: 978-1-62708-198-6
..., knee, and spinal implants, which were resolved after implant removal ( Ref 72 , 73 ). However, adjacent tissues in these case studies of spinal implants have shown the presence of synovial-like granulomatous tissue similar to that of virtually all hip and knee implants eventually. Thus, it is likely...
Abstract
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.
Image
Published: 01 June 2012
Fig. 9 Knee joint simulator used to evaluate magnitude and distribution of wear in a total replacement knee joint. (a) Complete machine setup showing test apparatus and accompanying state-of-the-art monitoring/recording instrumentation. (b) Closeup view of test cell showing knee joint implant
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Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006811
EISBN: 978-1-62708-329-4
... of occurrence is knee replacement or total knee arthroplasty (TKA). It is estimated that more than 125,000 TKA procedures would be performed in the United States in 2020 ( Ref 7 ). In addition to the aforementioned devices, other common types of orthopedic implants include artificial shoulders (shoulder...
Abstract
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.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005678
EISBN: 978-1-62708-198-6
... in a total replacement knee joint. (a) Complete machine setup showing test apparatus and accompanying state-of-the-art monitoring/recording instrumentation. (b) Closeup view of test cell showing knee joint implant being evaluated while it is held in position in a test fixture In Vivo Assessment of Total...
Abstract
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.
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Published: 01 December 1998
Fig. 1 Diagram of total hip and knee replacements showing component shape and location of implantation
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Book: Thermal Spray Technology
Series: ASM Handbook
Volume: 5A
Publisher: ASM International
Published: 01 August 2013
DOI: 10.31399/asm.hb.v05a.a0005741
EISBN: 978-1-62708-171-9
.... Artificial joints are used to replace diseased biological joints in hips, knees, shoulders, elbows, wrists, fingers, and so on. The typical hip joint implant is composed of four components: a stem, head, insert, and shell ( Fig. 1 ). Other joints have similar components but different geometries. A stem...
Abstract
This article provides an overview of how thermal spray technology has adapted to meet the needs of the orthopaedic industry. It includes the challenges facing the development of artificial joints, substrate material selection criteria, thermal spray solutions, and clinical outcomes of thermal spray coatings. The article focuses on plasma thermal spray, which is the technique most often used to make porous titanium and hydroxyapatite (HA) coatings, such as thermal spray titanium, thermal spray HA, solution-precipitated HA, thermal spray chromium oxide, and thermal spray chromium carbide cermet coatings.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005682
EISBN: 978-1-62708-198-6
... for cochlear and dental prostheses are manufactured using a plastic or ceramic material. However, for making total hip replacements and total knee replacements, metals are considered the best candidate due to their higher tensile load-bearing capabilities. The various parts of hip and knee implants require...
Abstract
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.
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