(b)(4).Reported event was confirmed by review of revision operative notes and product received.The taper surface on the femoral head and stem note dark debris consistent with taper corrosion.Debris was noted on the external articulating surface of the head.Sem images confirmed the presence of dark debris on the femoral head taper operative notes stated patient had adverse local tissue reaction.During procedure abundant amount of fluid under pressure that was in trochanteric bursa.A hole in the posterior capsular found.Some debris in the fluid, but was not cloudy.A mid amount of corrosion inside the head was noted.There was some adverse local tissue reaction behind the shell with some bone loss.There was some osteolysis around the proximal portion of the femoral component.Minimal metal debris behind the liner noted.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 1822565 - 2015 - 02219.
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It was reported patient¿s hip was revised approximately 2 years post implantation due to elevated metal ion levels, metallosis, corrosion, and adverse local tissue response.Attempts have been made and additional information on the reported event is unavailable at this time.
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