The device associated with this report was not returned.Follow up communication for product return was unsuccessful.A complaints review was completed in (b)(6) 2014 and in (b)(6) 2014 for all attune trial instruments, following 25,000 and 50,000 surgeries, inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted dfmea updates where applicable.Previous investigations found the root cause to be attributed to user technique and/or misuse.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, the need for corrective action was not indicated.Continue to monitor via sep-419.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.
|