Litigation alleges the patient suffers from pain, discomfort, inflammation, dislocation, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone.Update (b)(6) 2015 - pfs and medical records received.After review of the medical records for mdr reportability, it should be noted the patient had a poly liner implanted -not metal.Part/lot is being updated.No labs were provided for the alleged high metal ions.Update (b)(6) 2016 - pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported patient had pain, swelling, popping, grinding, hip catching, falls, back pain, nausea, vomiting, lack of sleep, numbness and tingling.Medical records reported the patient had a slip with groin pull, popping, grinding, swelling, pain, possible loosening, possible dislocations, and radiographs reportedly showed leg length discrepancy and slightly retroverted cup.There has been no reported revision surgery.Cup is being added to complaint for malposition.
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No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided lot since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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