Revision of acetabular components-put in by same surgeon in (b)(6) 2007.On x ray it appeared that the marathon liner had completely worn down, however, once the hip was exposed, it was apparent that the liner had completely disengaged from the pinnacle shell and the metal head was grinding on the shell.The corail stem remained in situ as it was well fixed.All acetabular components and the femoral head were removed.
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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.Product complaint # (b)(4).Investigation summary : the devices were reviewed by bioengineering and a report was received stating; it was unlikely that a manufacturing defect was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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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