(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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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.
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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 trunnions 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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