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Book Chapter
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001804
EISBN: 978-1-62708-241-9
... of failures in stainless steel orthopaedic implant devices fatigue failure due to improper fixation of a compression bone plate . J. Mater. Sci. Lett. 13 , 142 – 145 ( 1994 ) 10.1007/BF00416827 5. Breme J. , Titanium and titanium alloys, biomaterials of preference . Mèmoires et É tudes...
Abstract
A stainless steel screw securing an orthopedic implant fractured and was analyzed to determine the cause. Investigators used optical and scanning electron microscopy to examine the fracture surfaces and the microstructure of the austenitic stainless steel from which the screw was made. The results of the study indicated that the screw failed due to fatigue fracture stemming from surface cracks generated by stress concentration likely caused by grooves left by improper machining.
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001803
EISBN: 978-1-62708-241-9
.... orthopedic implant devices fracture corrosion inclusions and stress gaps medical materials cracking fretting pitting fractography fracture toughness Ti6Al4V (titanium-aluminum-vanadium alloy) UNS R56406 316L stainless steel (austenitic wrought stainless steel) UNS S31603 Introduction...
Abstract
Metallurgical SEM analysis provides many insights into the failure of biomedical materials and devices. The results of several such investigations are reported here, including findings and conclusions from the examination a total hip prosthesis, stainless steel and titanium compression plates, and hollow spinal rods. Some of the failure mechanisms that were identified include corrosive attack, corrosion plus erosion-corrosion, inclusions and stress gaps, production impurities, design flaws, and manufacturing defects. Failure prevention and mitigation strategies are also discussed.
Series: ASM Handbook Archive
Volume: 11
Publisher: ASM International
Published: 01 January 2002
DOI: 10.31399/asm.hb.v11.a0001819
EISBN: 978-1-62708-180-1
... Abstract This article commences with a description of the prosthetic devices and implants used for internal fixation. It describes the complications related to implants and provides a list of major standards for orthopedic implant materials. The article illustrates the body environment and its...
Abstract
This article commences with a description of the prosthetic devices and implants used for internal fixation. It describes the complications related to implants and provides a list of major standards for orthopedic implant materials. The article illustrates the body environment and its interactions with implants. The considerations for designing internal fixation devices are also described. The article analyzes failed internal fixation devices by explaining the failures of implants and prosthetic devices due to implant deficiencies, mechanical or biomechanical conditions, and degradation. Finally, the article discusses the fatigue properties of implant materials and the fractures of total hip joint prostheses.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001606
EISBN: 978-1-62708-226-6
..., these orthopedic devices are surgically implanted and affixed to bones, usually with screws of the same alloy composition. Fixation implants usually remain in the human body until the broken bone has healed sufficiently to sustain normal loading without the additional support provided by the implant. After several...
Abstract
Failures of four different 300-series austenitic stainless steel biomedical fixation implants were examined. The device fractures were observed optically, and their surfaces were examined by scanning electron microscopy. Fractography identified fatigue to be the failure mode for all four of the implants. In every instance, the fatigue cracks initiated from the attachment screw holes at the reduced cross sections of the implants. Two fixation implant designs were analyzed using finite-element modeling. This analysis confirmed the presence of severe stress concentrations adjacent to the attachment screw holes, the fatigue crack initiation sites. Conclusions were reached regarding the design of these types of implant fixation devices, particularly the location of the attachment screw holes. The use of austenitic stainless steel for these biomedical implant devices is also addressed. Recommendations to improve the fixation implant design are suggested, and the potential benefits of the substitution of titanium or a titanium alloy for the stainless steel are discussed.
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
... 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...
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 Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001690
EISBN: 978-1-62708-226-6
... , p. 12 . 15. Daniel A.U. and Dunn H.K. : Proc. Symp. on Retrieval and Analysis of Orthopedic Implants , NBS Special Publication 472 , Maryland , 1976 , pp. 61 – 71 . 16. Anon : Medical Equipment and Devices Industry , International Trade Data System, 2001. http...
Abstract
This paper summarizes several cases of metallurgical failure analysis of surgical implants conducted at the Laboratory of Failure Analysis of IPT, in Brazil. Investigation revealed that most of the samples were not in accordance with ISO standards and presented evidence of corrosion assisted fracture. Additionally, some components were found to contain fabrication/processing defects that contributed to premature failure. The implant of nonbiocompatible materials results in immeasurable damage to patients as well as losses for the public investment. It is proposed that local sanitary regulation agencies create mechanisms to avoid commercialization of surgical implants that are not in accordance with standards and adopt the practice of retrieval analysis of failed implants. This would protect the public health by identifying and preventing the main causes of failure in surgical implants.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001664
EISBN: 978-1-62708-226-6
... Orthopedic Implants,” Journal of Biomedical Materials Research , Vol. 3 , pp. 247 – 265 ( 1969 ). 2. Hughes A. N. and Jordan B. A. , “Metallurgical Observations on Some Metallic Surgical Implants Which Failed in Vivo,” Journal of Biomedical Materials Research , Vol. 6 , pp. 33...
Abstract
A compression hip screw is a device designed to hold fractures in the area of the femur in alignment and under compression. A side plate, which is an integral part of the device, is attached by screws to the femur, and it holds the compression screw in position. The device analyzed had broken across the eighth hole (of nine holes) from the end of the plate. The detailed metallurgical failure analysis of the device, including metallography and fractography, is reported here. It was found that the device had adequate metallurgical integrity for the application for which it was intended. It is believed that failure was caused by the lack of a screw in the ninth hole. Evidence is also presented which indicates that the device was bent prior to insertion, and the local plastic deformation may have caused structural changes leading to premature crack initiation.
Series: ASM Failure Analysis Case Histories
Volume: 1
Publisher: ASM International
Published: 01 December 1992
DOI: 10.31399/asm.fach.v01.c9001097
EISBN: 978-1-62708-214-3
... Abstract Two type 316L stainless steel orthopedic screws broke approximately 6 weeks after surgical implant. The screws had been used to fasten a seven-hole narrow dynamic compression plate to a patient's spine. The broken screws and screws of the same vintage and source were examined using...
Abstract
Two type 316L stainless steel orthopedic screws broke approximately 6 weeks after surgical implant. The screws had been used to fasten a seven-hole narrow dynamic compression plate to a patient's spine. The broken screws and screws of the same vintage and source were examined using macrofractography, SEM fractography, and hardness testing. Fractography established that fracture was by fatigue and that the fatigue cracking originated at corrosion pits. Hardness while below specification, still indicated that the screws were in the cold-worked condition and notch sensitive during fatigue loading. Use of a steel with a higher molybdenum content (317L) in the annealed condition was recommended.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001579
EISBN: 978-1-62708-226-6
... unilateral bending. The bending loads were presumably a consequence of leg oscillation during assisted perambulation. Inclusion 316L UNS S31603 Corrosion fatigue Exposure by orthopaedic implants to the biomechanical and biochemical forces and interactions between the implants and the biological...
Abstract
Stainless steel is frequently used for bone fracture fixation in spite of its sensitivity to pitting and cracking in chloride containing environments (such as organic fluids) and its susceptibility to fatigue and corrosion fatigue. A 316L stainless steel plate implant used for fixation of a femoral fracture failed after only 16 days of service and before bone callus formation had occurred. The steel used for the implant met the requirements of ASTM Standard F138 but did contain a silica-alumina inclusion that served as the initiation point for a fatigue/corrosion fatigue fracture. The fracture originated as a consequence of stress intensification at the edge of a screw hole located just above the bone fracture; several fatigue cracks were also observed on the opposite side of the screw hole edge. The crack propagated in a brittle-like fashion after a limited number of cycles under unilateral bending. The bending loads were presumably a consequence of leg oscillation during assisted perambulation.
Series: ASM Failure Analysis Case Histories
Volume: 2
Publisher: ASM International
Published: 01 December 1993
DOI: 10.31399/asm.fach.v02.c9001265
EISBN: 978-1-62708-215-0
... Junctions Porous coatings have been developed for orthopedic use primarily to provide a space into which bone can grow and mineralize, locking the device into place. This is termed biological fixation. During loading, however, this porous network is subjected to variable and nonintuitive stresses...
Abstract
Total knee prostheses were retrieved from patients after radiographs revealed fracture of the Ti-6A1-4 VELI metal backing of the polyethylene tibial component. The components were analyzed using scanning electron microscopy. Porous coated and uncoated tibial trays were found to have failed by fatigue. Implants with porous coatings showed significant loss of the bead coating and subsequent migration of the beads to the articulating surface between the polyethylene tibial component and the femoral component, resulting in significant third-body wear and degradation of the polyethylene. The sintered porous coating exhibited multiple regions where fatigue fracture of the neck region occurred, as well as indications that the sintering process did not fully incorporate the beads onto the substrate. Better process control during sintering and use of subsequent heat treatments to ensure a bimodal microstructure were recommended.
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001801
EISBN: 978-1-62708-241-9
... fixation device fracture surface damage titanium alloy notches roughness metallography fatigue crack growth rates ASTM F136 (alpha-beta titanium alloy) UNS R56401 Introduction The Harrington rod, developed in 1953 by Paul Harrington, a professor of orthopedic surgery at Baylor College...
Abstract
Both rods in a Harrington rod cervical stent failed after a short time in service. Metallurgical analysis revealed a significant number of notches as well as enlarged grain size in one of the two rods, rough shallow-cracked surfaces along the bend profiles, possible signs of corrosion, and fractures (on both rods) near indentations imparted by retaining clamps. The observations suggest that surface roughness and bending defects initiated cracking that led to the fatigue failure of the compromised rod, followed some time later by the overload fracture of the second rod.
Series: ASM Failure Analysis Case Histories
Volume: 2
Publisher: ASM International
Published: 01 December 1993
DOI: 10.31399/asm.fach.v02.c9001264
EISBN: 978-1-62708-215-0
... • Pohler O.E.M. , Failures of Metallic Orthopedic Implants , Failure Analysis and Prevention , Vol 11 , ASM Handbook , ASM International , 1986 , p 670 – 694 10.31399/asm.hb.v11.a0001819 Handbook of Case Histories in Failure Analysis, Volume 2 Copyright © 1993 ASM International® K.A...
Abstract
A type 316L stainless steel “Jewett nail” hip implant failed after 2 months of service. Fracture occurred through the first of five screw holes in the plate section. Microscopic examination of mating fracture surfaces showed that failure had initiated at the outside (convex) surface of the plate and proceeded through its thickness. The fracture morphology was characteristic of fatigue. A beveled area on the inside surface of the plate indicated that the implant had been fractured for some time prior to removal. Metallographic examination of samples cut from the plate section revealed a series of hidden repair welds on the inside surface of the plate in the vicinity of the fracture. Comparison of the microstructure in the area of the fracture with that in an area away from the weld indicated that the repair welding had resulted in the creation of an annealed, softened zone. Manufacturers should never attempt to salvage this type of critical device by welding or any other procedure that might compromise its integrity.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.homegoods.c9001610
EISBN: 978-1-62708-222-8
... are delivered to the implant manufacturer, are cold-draw, pickled, ground, and polished. For example, ISO 5839 10 requires that the surfaces of orthopedic prostheses present satin and/or mirror polished finishing (depending on the surface). Electropolishing is accepted as a method to obtain final surface...
Abstract
This investigation characterizes five surgical stainless steel piercings and one niobium piercing that caused adverse reactions during use, culminating with the removal of the jewelry. Chemical composition shows that none of the materials are in accordance with ISO standards for surgical implant materials. Additionally, none of the stainless steel piercings passed the pitting-resistance criterion of ISO 5832-1, which implies that [%Cr + 3.3(%Mo)] > 26. Under microscopic examination, most of the jewelry revealed the intense presence of linear irregularities on the surface. The lack of resistance to pitting corrosion associated with the poor surface finishing of the stainless steel jewelry may induce localized corrosion, promoting the release of cytotoxic metallic ions (such as Cr, Ni, and Mo) in the local tissue, which can promote several types of adverse effects in the human body, including allergic reactions. The adverse reaction to the niobium jewelry could not be directly associated with the liberation of niobium ions or the residual presence of cytotoxic elements such as Co, Ni, Mo, and Cr. The poor surface finish of the niobium jewelry seems to be the only variable of the material that may promote adverse reactions.
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.9781627083294
EISBN: 978-1-62708-329-4
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048400
EISBN: 978-1-62708-226-6
... to intercrystalline corrosion and implant separation. The wire came from a source different from that of the screws and washers and did not meet current standards for orthopedic wire. Reference Reference 1. Müller M.E. , Allgöwer M. , Schneider R. , and Willenegger H. , Manual...
Abstract
Cerclage wire, which was used with two screws and washers for a tension band in a corrective internal fixation, was found broken at several points and corroded after nine months in service. The material was examined using energy-dispersive x-ray analysis and determined not to be in compliance with standards (type 304 stainless steel without molybdenum). The screws and washers were found to be made of remelted implant-quality type 316L stainless steel and were intact. Signs of sensitization, characterized by chromium carbide precipitates at the grain boundaries, were revealed by the microstructure. Intercrystalline corrosion with pitted grains was indicated by SEM fractography. Improper heat treatment of the steel was interpreted to have led to intercrystalline corrosion and implant separation.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0089543
EISBN: 978-1-62708-226-6
..., Columbus Metallurgical Services, Inc., Columbus, Ohio. Selected Reference Selected Reference • Pohler O.E.M. , Failures of Metallic Orthopedic Implants , Failure Analysis and Prevention , Vol 11 , ASM Handbook , ASM International , 1986 , p 670 – 694 10.31399/asm.hb.v11.a0001819 ...
Abstract
Threads of a bone screw (Co-Cr-Mo alloy, type ASTM F75) had broken off, and other threads had cracked. 15x sectioning showed porosity, and 155x magnification showed gas holes, segregation, and dissolved oxides. This supports the conclusion that manufacturing defects caused the failure.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001573
EISBN: 978-1-62708-226-6
... likely caused the microarcing and hence the failure. Selected Reference Selected Reference • Pohler O.E.M. , Failures of Metallic Orthopedic Implants , Failure Analysis and Prevention , Vol 11 , ASM Handbook , ASM International , 1986 , p 670 – 694 10.31399/asm.hb.v11.a0001819 ...
Abstract
TiN coated back surgery wires were made of Ti-6Al-4V. The reported failure was the presence of pits located in the uncoated area of the wires. The uncoated area of the wire is where the wire is fixtured in the coating chamber during coating. Examination and analysis of the pits using SEM/EDX detection unit revealed significant peaks of B, O, Zr and Fe. Moreover, the shape of the pits was similar to an arc crater. The formation of pits in the wire was caused during coating due to microarcing. A contaminated fixture used during the coating most likely caused the microarcing.
Book Chapter
Series: ASM Handbook Archive
Volume: 11
Publisher: ASM International
Published: 01 January 2002
DOI: 10.31399/asm.hb.v11.a0003562
EISBN: 978-1-62708-180-1
..., clutches, spindles, and seals; in press fits on shafts; and in universal joints, base plates, shackles, and orthopedic implants. Generally, fretting occurs at contacting surfaces that are intended to be fixed in relation to each other but that actually undergo minute alternating relative motion...
Abstract
This article reviews the general characteristics of fretting wear in mechanical components with an emphasis on steel. It focuses on the effects of physical variables and the environment on fretting wear. The variables include the amplitude of slip, normal load, frequency of vibration, type of contact and vibration, impact fretting, surface finish, and residual stresses. The form, composition, and role of the debris are briefly discussed. The article also describes the measurement, mechanism, and prevention of fretting wear. It concludes with several examples of failures related to fretting wear.
Series: ASM Handbook
Volume: 11
Publisher: ASM International
Published: 15 January 2021
DOI: 10.31399/asm.hb.v11.a0006829
EISBN: 978-1-62708-295-2
... on shafts; and in universal joints and orthopedic implants. Generally, fretting occurs at contacting surfaces that are intended to be fixed in relation to each other but that actually undergo small oscillating motion usually induced by vibration. Other situations concern cyclic thermal dilatation...
Abstract
Fretting is a wear phenomenon that occurs between two mating surfaces; initially, it is adhesive in nature, and vibration or small-amplitude oscillation is an essential causative factor. Fretting generates wear debris, which oxidizes, leading to a corrosion-like morphology. This article focuses on fretting wear related to debris formation and ejection. It reviews the general characteristics of fretting wear, with an emphasis on steel. The review covers fretting wear in mechanical components, various parameters that affect fretting; quantification of wear induced by fretting; and the experimental results, map approach, measurement, mechanism, and prevention of fretting wear. This review is followed by several examples of failures related to fretting wear.
Series: ASM Handbook
Volume: 11B
Publisher: ASM International
Published: 15 May 2022
DOI: 10.31399/asm.hb.v11B.a0006918
EISBN: 978-1-62708-395-9
... An Ultrahigh-molecular-weight polyethylene (UHMWPE) is a semicrystalline polymer used widely in orthopedic applications due to its exceptional energetic toughness, biocompatibility, and wear resistance ( Ref 70 ). Figure 2 depicts crack growth in an UHMWPE sample. Ultrahigh-molecular-weight polyethylene has...
Abstract
This article reviews generalized test methodologies for fatigue characterization of polymers and examines fatigue fracture mechanisms in different engineering plastics. It provides detailed micromechanistic images of crack-tip processes for a variety of semicrystalline and amorphous engineering polymers. The article describes fracture mechanics solutions and approaches to the fatigue characterization of engineering polymers when dealing with macroscale fatigue crack growth. It includes mechanistic images for high-density polyethylene, ultrahigh-molecular-weight polyethylene, nylon 6, 6, polycarbonate, and polypropylene. The article describes the micromechanisms of toughening of plastics and uses a macroscale approach of applying fracture mechanics to the fatigue life prediction of engineering polymers, building on the mechanistic concepts. It also describes the factors affecting fatigue performance of polymers.
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