Litigation alleges pain, discomfort, limited mobility, grinding sensations, audible squeaking and toxic cobalt and chromium metal debris to be released into the tissue.Records indicate that the patient was revised because the liner was loose from the shell.Records are available for further review.Ppf alleges loosening of cup.Pfs alleges that the surgical leg was an inch longer than the healthy side causing intense pain in the lower back.After review of medical records for the mdr reportability, patient was revised to address failed tha.Intraop findings reported of ho along the outer aspect of the cement block and a little on the medial side of the cup.The cement was removed without difficulty.The inner cup was loose.There was a fibrous interface but the cup was mobile and had created a thin black membrane of metal debris from the screw heads moving against the cup.There was significant instability with a 4-6 mm shuck when restoring the hip's normal position.Doi: (b)(6) 2010 - dor: (b)(6) 2011(left 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 will be filed as appropriate.
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