The complaint sample was evaluated and the complaint was confirmed.Visual inspection of the devices shows circular grooves on the bottom of the insert are deformed/stripped and 2 cuts marks run from the top to the bottom, possibly during attempts to remove the taper insert from the trunnion.Cmm results confirm that measured dimensions were within tolerance.The taper hole on the returned device shows some metal debris and was submitted for further debris analysis.Optical imaging revealed discoloration of the inner morse taper of the taper insert.Sem examination revealed dark-imaging deposits on the backside of the taper insert and within the taper bore.Quantitative eds analysis of the deposits on the backside of the taper insert and within the morse taper showed combinations of : biological material containing some or all of the elements c, n, o, na, mg, p, s, cl and ca; substrate titanium alloy containing the elements ti, al and v; elevated levels of oxygen (possibly oxidized taper corrosion products).A deposit-free region of the backside of the taper insert was analyzed and found to be consistent with ti6al4v alloy.Device history records were reviewed and no deviations or anomalies in the manufacturing process that would have affected the surgical outcome or contributed to the reported event.A definitive root cause for the reported event could not be determined with the information available.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.
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