(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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Pinnacle medical records received.After review of medical records, the patient complained of increasing discomfort, pain and had elevated cobalt chromium levels in blood.The patient was then revised for metallosis of the left metal on metal hip.Operative notes reported that a 10 cc of brown-black synovial fluid was removed.The synovium demonstrated chronic inflammation with brown/black staining.There was extensive trunnionosis with corrosion on the morse taper aspect of the head as well as the trunnion.Doi: (b)(6) 2007; dor: (b)(6) 2019; left hip.
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