Reported event was unable to be confirmed due to limited information received from the customer.Review of the dhr found the product was released to distribution with no deviations or anomalies.Review of the complaint history determined that no further action is required as no were trends identified.Current information is insufficient to permit conclusions as to the cause of the events.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.(b)(4).
|