(b)(4).(udi): n/a.Concomitant medical products: catalog #: unknown, screw, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.Reported event was considered confirmed as the x-rays showed evidence of loosening, fractured screw, and possible fracture nonunion of a intertrochanteric hip fracture.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01393.
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It was reported that the patient underwent an initial surgery at an unknown date.Subsequently the patient has been indicated for a revision, however, a revision has not been reported.It was seen by the x-ray that the revision occurred due to loosening and a screw fracture.No additional information is available.
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