Complaint description: litigation alleges the patient suffers from pain, swelling, instability, lack of mobility, elevated chromium and cobalt levels, extensive metallosis around the hip, necrosis in the posterior capsule, inferior capsule, and to a lesser degree anteriorly.Update 2/10/2015 - pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated metallosis, instability, pain, swelling, and increased metal ions (no labs provided).The revision operative note also indicated a loose hip, but didnt indicate a specific implants.All implants were revised.This complaint was updated on 3/4/2015.Update 27 apr 2018: (b)(4) has been re-opened under (b)(4) due to ppf and sticker sheets.In addition to what were previously alleged, ppf alleges loosening of cup and stem, dislocation.Added cup, screws, medical history and law firm.Doi: (b)(6) 2008 -dor: (b)(6) 2014 (right hip).
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Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.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.Device history lot : null.Device history batch : null.Device history review : null.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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