(b)(4).Concomitant medical products: unknown screw multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03140.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A definitive root cause cannot be determined, however a probable root cause of the liner not seating is contributed to the screws not seated fully.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.
|
It was reported that the liner would not seat and caused difficulty with the inserter disengaging.Upon examination, it was discovered that the screws were not inserted correctly and were sitting proud.Surgery was delayed by 60 minutes.Attempts were made to obtain additional information; however, none was available.
|