There was a revision to remove the loosened screw during a clinical study, therefore the complaint is considered confirmed.Functional testing and inspections could not be performed due to the part not being returned.More than three attempts were made for additional information and materials such as photographs, scans, x-rays, and/or physician's reports, however no new information was yielded.Device history record (dhr) review was unable to be performed as the part number and 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.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.
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