(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # unknown/ unknown head / lot # unknown.Part #unknown / unknown liner / lot # unknown.Part # unknown/ unknown cup/ lot # unknown.Part # unknown/ unknown stem/ lot #unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01605, 0001825034-2020-01606.
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It was reported patient underwent hip surgery approximately 2 years post implantation due to elevated metal ions, pain, peripheral neuropathy memory and balance issues, fatigue, sleep disturbances, positive pet scan for chronic toxic encephalopathy and ct scan for fluid at right hip.It was noted that during the revision, cloudy fluid, metallic staining, corrosion of head/trunnion, tissue had appearance of altr and fish flesh appearance.Attempts have been made and additional information on the reported event is unavailable at this time.
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