Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that the patient had hip replaced some time ago where he received a srom stem with a pinnacle cup and a ultamet metal liner.According to surgeon, the patients cobalt serum levels where elevated and was experiencing some discomfort in his hip.Surgeon decided he would revise the patients hip and exchange the metal liner for a polyethylene liner.During the surgery, surgeon was able to explant the metal liner, hole eliminator, and srom metal femoral hip ball.The pinnacle cup, srom stem, and srom sleeve were left in situ.A new poly liner and ceramic srom femoral hip ball was implanted.Original implant date unknown.Doi: unknown; dor: (b)(6) 2020 (right hip).
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