Litigation alleges that the patient suffers from pain, discomfort, inflammation, dislocation, disarticulation, and/or a slipping feeling, and large amounts of toxic cobalt chromium metal ions and particles to be released into the blood, tissue, and bone.Update: 7/8/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Update ad 17 jul 2018: receipt of ppf and medical records.In addition to what were previously alleged, ppf alleges metal wear, metallosis and elevated metal ions.Added stem due to new allegation.Update ad 11 mar 2019: based on to do task: added pe code implant - implant fit: mating parts do not disassemble" as well as the patient code "prolonged surgery" to the liner and cup.Removed the "implant fracture post-op: metal" from the two screw ips and added "adverse event: no product problem" codes.
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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 will be filed as appropriate.
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