(b)(4).Concomitant medical products: shell pn 00620005422/ ln unknown.Liner 10 degree pn 00631005032/ ln 60963079.Femoral body pn 00999301835/ ln unknown.Reported event was confirmed by review of medical records and device examination.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual evaluation of the head identified dark debris and a thread like pattern on the surface of the conical taper.No other damages were noted.Sem analysis of the head revealed deposits on the taper surface and circumferential grooves, possibly from contact with the surface texture of the stem's taper.Circumferential bands of deposits were observed in the taper.Axial wear or corrosion marks and surface pitting was noted.Quantitative eds of the taper's surface identified the following - 1) biological material containing some or all of c, na, o, p, s, cl, and ca.2) cocrmo substrate material showing elevated levels of cr, mo, and o, possible evidence of corrosion products.3) titanium, possibly transferred from the stem taper.Eds analysis of the polished bearing surface of the head was consistent with cocrmo alloy.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
It was reported that patient underwent total hip arthroplasty.The patient underwent a revision procedure seven years later due to pseudotumor, corrosion, pain, altr, necrosis, and an allergic reaction.Trunnion was acceptable, head was revised.No additional information is available.
|