Additional narrative: the duraloc cup was revised due to polyethylene wear.Examination of the reported devices was not possible as they were not returned.Review of the liner device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.No other reports found against the remaining product/lot code combinations.X-rays were reviewed.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy still considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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