Reported event was able to be confirmed via complaint history review.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definite root cause has not yet been determined, however, remedial action has been initiated.No correction//removal number has been received.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|