(b)(4).Medical products - unknown oss tibial tray catalog # unknown lot # unknown, unknown oss bearing catalog # unknown lot # unknown, unknown oss auguments catalog # unknown lot # unknown, unknown oss femoral catalog # unknown lot # unknown, unknown oss stems catalog # unknown lot # unknown.(b)(4).Customer has indicated that the product will not be returned because product location is unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.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.X-ray review indicates there is a radiodense structure seen slightly protruding in the posterosuperior hoffa's fat pad region could represent backing out of the distal locking screw, however, this cannot be confirmed based on the single image 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 filled for this event: 0001825034-2017-09505.
|