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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

A cast stainless steel femoral head replacement prosthesis fractured midway down the stem within 13 months of implantation. Visual examination showed severe “orange peel” around the fracture on the concave side. This effect was not observed on the convex side, which suggested fatigue fracture. Metallographic examination of samples revealed an extremely large grain size and corroborated fatigue fracture. Chemical analysis indicated that the material conformed to the requirements for type 316L stainless steel. Substandard-size tensile bars machined from another prosthesis from the same manufacturer showing identical grain sizes were used for mechanical testing. Tensile tests indicated that the material did not meet the manufacturer's stated strength criteria in the portion of the stem that fractured. The failure was attributed to low strength, which resulted in fatigue. The extremely coarse grain size was considered a major factor in strength reduction.

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.

This article describes the failure characteristics of high-pressure long-distance pipelines. It discusses the causes of pipeline failures and the procedures used to investigate them. The use of fracture mechanics in failure investigations and in developing remedial measures is also reviewed.

This article addresses the forms of corrosion that contribute directly to the failure of metal parts or that render them susceptible to failure by some other mechanism. It describes the mechanisms of corrosive attack for specific forms of corrosion such as galvanic corrosion, uniform corrosion, pitting and crevice corrosion, intergranular corrosion, and velocity-affected corrosion. The article contains a table that lists combinations of alloys and environments subjected to selective leaching and the elements removed by leaching.

Corrosion is the electrochemical reaction of a material and its environment. This article addresses those forms of corrosion that contribute directly to the failure of metal parts or that render them susceptible to failure by some other mechanism. Various forms of corrosion covered are galvanic corrosion, uniform corrosion, pitting, crevice corrosion, intergranular corrosion, selective leaching, and velocity-affected corrosion. In particular, mechanisms of corrosive attack for specific forms of corrosion, as well as evaluation and factors contributing to these forms, are described. These reviews of corrosion forms and mechanisms are intended to assist the reader in developing an understanding of the underlying principles of corrosion; acquiring such an understanding is the first step in recognizing and analyzing corrosion-related failures and in formulating preventive measures.

This article provides an overview of the electrochemical nature of corrosion and analyzes corrosion-related failures. It describes corrosion failure analysis and discusses corrective and preventive approaches to mitigate corrosion-related failures of metals. These include: change in the environment; change in the alloy or heat treatment; change in design; use of galvanic protection; use of inhibitors; use of nonmetallic coatings and liners; application of metallic coatings; use of surface treatments, thermal spray, or other surface modifications; corrosion monitoring; and preventive maintenance.