Reason for original complaint- patient was revised to address acetabular loosening.Medical records were obtained.Medical records indicate patient was revised due to pain.Upon revision, mildly elevated metal ion levels, cloudy fluid, elevated sed rate and c-reactive protein, and a positive gram stain consistent with infection were found.Asr litigation records received alleging injury, economic loss, loss of services, pain, suffering and emotional distress.Doi: (b)(6) 2007; dor: none reported (right hip).There was no revision reported on the litigated records.However, previously received documents regarding this patient indicate that the patient had undergone revision on (b)(6) 2011.
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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.If information is obtained that was not available for the initial meadwatch, a follow-up medwatch will be filed as appropriate.
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