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.

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.

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.

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.

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.

A type 316L stainless steel angled plate failed. The fatigue fracture was found to have occurred at a plate hole. Symmetric cyclic bending forces were revealed by the fatigue damage at the fracture edge at the top surface of the plate. Fatigue striations and slip bands produced on the surface during cyclic loading were observed. The material was showed by the deformation structure to be in the cold-worked condition and was termed to not be the cause of the implant failure.

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 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.

Heavy pitting corrosion on type 304 stainless steel bone screw was studied. A screw head that exhibited heavy pitting corrosion attack was observed. Deep tunnels that penetrated the screw head and followed the inclusion lines were revealed. The screw was inserted in a plate made of type 316LR stainless steel and some mechanical fretting and very few corrosion pits were revealed. Type 304 stainless steel was deemed not to be satisfactory as an implant material.

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.

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.

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.

Wear on a titanium screw head with a lip of material that that was transported by fretting at a plate-hole edge was studied. A flat fretting zone was visible on the screw surface over the material lip. A cellular wear structure containing wear debris was found. No morphological signs of corrosion were observed in connection with fretting structures.

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.

A large portion of the four-hole Lane plate disintegrated and consisted mainly of corrosion products after remaining in the body for 26 years. Transformation structures and carbides were exhibited by the plate which was made from chromium steel. Minimal corrosion was exhibited by the soft austenitic 304 stainless steel used to make the screws. The corrosion products of the plate were revealed by microprobe analysis to impregnate the surrounding tissues. Improper material selection was concluded to be the reason for the general corrosion behavior.

Type 316LR stainless steel screws that failed by fatigue were studied. It was found that fatigue fracture can occur on different thread levels, depending on the loading situation. The initiation of secondary fatigue cracks was occasionally found parallel to the fracture plane. The screws were used with a relatively rigid plate to treat a fracture complication in the upper end of the femur. The fatigue failures were explained by signs of unstable fixation revealed by radiographs.

Fretting and fretting corrosion at the contact area between the screw hole of a type 316LR stainless steel bone plate and the corresponding screw head was studied. The attack on the 316LR stainless steel was only shallow. Mechanical grinding and polishing structures were exhibited by a large portion of the contact area. Fine corrosion pits in the periphery were observed and intense mechanical material transfer that can take place during fretting was revealed. Smearing of material layers over each other during wear was observed and attack by pitting corrosion was interpreted to be possible.

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.

Two of four adjustable Moore pins, which had been used to stabilize a proximal femur fracture, were found to be broken and deformed at their threads. The pins were made from a cobalt-chromium alloy and were not in the same condition. Brittle precipitates in the grains and grain boundaries were seen in one of the pins and hence the fracture was revealed to have occurred along the grain boundaries. The other pin made from cold-worked cobalt-chromium alloy was observed to have randomly lines of primary inclusions. Intermingled dimples and fatigue striations were exhibited on the fracture surface of this pin. Thus, the effect of different conditions of cobalt-chromium alloys on failure behavior was demonstrated as a result of this study.

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.