The device associated with this report was not returned.The initial report stated the device would not be returned for evaluation.(b)(4) was held on 25 jan 2016 to evaluate the increased complaints involving the attune tibial trial extactor (product code 254500138).The review team determined that there was no increased patient risk.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the inability to identify root cause and (b)(4) determination of no additional patient risk, corrective action was not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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