Pinnacle claim submission form and medical records received.After review of medical records the patient was revised to address aseptic loosening femoral component with osteolysis acetabulum component, pain, subsidence, and leg length discrepancy.It was also indicated that x-rays demonstrated grossly loose femoral component with some subsidence and some osteolysis around her acetabular component and acetabulum is somewhat vertical, and she has an srom cup in place which is known to have good wear characteristics.Patient seems to be a person who does react to the polyethylene debris.It was also indicated operative notes reported femoral component was loose and thick membrane was removed.Doi: 2001; dor: (b)(6) 2009; left hip (1st revision).
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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 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 report, a follow-up report will be filed as appropriate.
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