Litigation alleges the patient suffers from inflammation, pain, discomfort, a limp, and large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone.Update 03/19/2015- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain and metallosis.No labs were provided for the alleged high metal ions.The complaint was updated on: 03/30/2015.Update ad 9 oct 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges stroke and heart attack.Added patient initial, hospital, law firm.Cup and screw was added due to ppf allegation.Doi: (b)(6) 2009.Dor: (b)(6) 2012, (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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