Pfs and ppf have no allegations.After review of medical records, the patient underwent revision surgery for reimplantation of definitive implants post prostalac placement.During surgery, there was fluid within the joint and a significant amount of scar tissue.Pieces of bone from the acetabular rim were retrieved.A femoral fracture was discovered but this was attributed to when the previous stem was being taken out.The patient was cleared of the infection.Surgical pathology reports fibrosis.Doi: (b)(6) 2013; dor: (b)(6) 2013 (right hip).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 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.Device history lot: null.Device history batch: null.Device history review: null.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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