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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6.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.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).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.H10 additional narrative: removed (3191) device revision or replacement no code available is used to capture generalized illness and surgical intervention.
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