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, 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.(b)(4).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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Pinnacle medical records received.After review of medical records, the patient was revised due to wear of articulating bearing surface.Clinic visit reported of pain, trouble walking, discomfort, tenderness, inflammation, weakness and workup revealed abnormal soft tissue reaction around the hip.Operative note reported, there was scarring of the short external rotators of the posterior capsule.Dark stained synovial fluid tissue and fluid was noted and evidence of adverse local soft tissue reaction.The cup was well fixed and decided to retain it.There was extensive caseating material in the proximal femur and there was hypertrophic synovium, with dark staining of the tissues, as well as caseating material in the pubis and the ischium.Laboratory result for cobal and chromium were below 7 ppb.Doi: (b)(6) 2009; dor: (b)(6) 2019; left hip.
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