…FDA said it is still concerned about hip implants in general, and most
especially with respect to how they are worn down. In the case of metal-on-metal
hips, the chromium coatings of the device wore each other down, in some cases
dislodging metal chromium shavings that caused tissue damage and raised fears
about metal ions entering the bloodstream and causing cancer…
…FDA noted that "there is renewed concern of wear and corrosion of conical
head/stem taper junctions in modern modular total hip replacements"…
…FDA said it’s embarking on a new project to "investigate the potential
link between volumetric wear and corrosion of conical head/stem taper junctions
in explanted total hip replacements and clinical outcomes" …
…The study will reportedly look at 250 explanted metal-on-metal hip
replacements of various sizes and genders and use the American Society for
Testing and Materials (ASTM) protocol for corrosion testing to analyze them.
"De-identified patient data and radiographs must be available or obtainable for
all devices," the notice explains.
The end goal of the project, which should take about two years total to
conduct, is to generate a peer-reviewed journal article explaining correlations
between wear and corrosion and relevant parameters (e.g. implantation time,
lateral offset, head size, materials, and modularity).