Update 25 sep 018 (b)(4) has been re-opened under (b)(4) due to receipt of pfs and medical records.Pfs alleges pseudotumor, metallosis, metal wear and abnormal gait when walking.After review of medical records, patient was revised to addressed painful right hip, metal wear and elevated metal ions.Operative findings reported of synovitis , weakness and metal wear.Revision notes reported of trunnion wear and bursitis present on femoral head neck junction.It was also indicated that cup was also revised since the liner would not dis-impact from the cup.Added account name, law firm, lawyer, age of patient, gtin, stem due to trunnion and date of revision.Corrected patient's initial.Doi: (b)(6) 2007; dor: (b)(6) 2016; right hip.
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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 medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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