FE Investigation of Design and Quality Control-Related Issues Contributing to Metal-On-Metal Hip Implant Failures
Keywords:Medical Device, Mechanically Assisted Crevice Corrosion, Hip Implant, Tribocorrosion, Taper Wear, Metallosis, Forensic Engineering, Design, Quality Control
High levels of cobalt and chromium ions were detected in the bodies of multiple recipients of modular cobalt chrome molybdenum metal-on-metal hip implants, necessitating the revision of their implants. A forensic engineering investigation of provided discovery documents and existing literature regarding the design, manufacturing, and clinical testing of these modular hip implants was performed. The investigation revealed that the modular interfaces of the implant allowed for micromotion to induce mechanically assisted crevice corrosion at these surfaces. The debris from this corrosion resulted in the release of metal ions into the bodies of the users, forming pseudotumors and compromising the user’s health and wellbeing. The effect of this corrosion was enhanced by the galvanic couple that existed between the modular components of the implant. In addition, scanning electron microscopy (SEM) and electron dispersive spectroscopy (EDS) analysis identified silicon carbide (SiC) and aluminum oxide (AL2O3 ) particles left behind from polishing, which were embedded in the ball and liners. These particles accelerated the wear of the hip implant and further exacerbated the release of metal ions. The designers of future hip implants should take care in preventing the occurrence of the above-stated factors.
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