The patient was revised for unknown reason.Asr products were revised.Update ad 05 feb 2020: (b)(4) has been reopened under (b)(4) due to receipt of asr litigation records alleging injury, economic loss, suffering, discomfort, soreness, swelling, severe metallosis, pseudotumors, malaise, loss of energy, immobilization, acute localized damage to tissue and/or bone, mental pain and suffering, excessive levels of chromium and cobalt, pain and emotional distress.Doi: (b)(6) 2006.Dor: (b)(6) 2017, (left hip).Update ad 10 feb 2020: plaintiff's preliminary disclosure and medical records received.There are no allegations from the ppd.After review of medical records, the patient was revised to address right hip mechanical failure.Patient was experiencing pain, metal on metal reaction and lysis.Intraoperatively, there was a large amount of fluid within the hip, a large cystic like mass consistent with a pseudotumor, lytic areas and mild trunnions around the trunnion.Doi: (b)(6) 2006.Dor: (b)(6) 2017, (right hip).
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.No code available is used to capture generalized illness.
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