Litigation alleges the patient suffers from pain, metallosis, abnormal tissue formation, difficulty ambulating and discomfort.Update ad 24 jul 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and implant records.In addition to what were previously alleged, ppf alleges metal wear and elevated metal ions.
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Product complaint # = > (b)(4).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.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.Device history lot = > d2vgb1.Device history review = > no related deviations or anomalies were identified.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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