Patient was revised to address elevated cobalt/chrome levels, along with radiographic changes in her hip.Update: 4/5/13 - litigation papers received.Litigation alleges pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ions and particles to be released into the patient's bone, blood, and bone.Update ad 30 oct 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf, pfs, sticker sheets and medical records.In addition to what were previously alleged, ppf alleges loosening of cup, fracture (bone) and metallosis.Pfs alleges, range of motion, osteolysis, metallosis and fracture.After review of medical records, patient was revised to address failed right metal on metal total hip arthroplasty with osteolysis and metallosis.Revision notes reported metal debris was encountered with evidence of metallosis.It was also stated that the cup appeared to have good fixation.Added date of birth, lawyer, medical history, laboratory data, facility name, account name, patient harm, udi, expiration date of head and unknown hip implant due to alleged fracture (bone).Corrected patient identifier.Doi: (b)(6) 2004; dor: (b)(6) 2013; (right hip).Please see (b)(4) for the allegation after fist revision.
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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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