(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 04072, 0001825034 - 2018 - 04073, 0001825034 - 2018 - 04074, 0001825034 - 2018 - 04075.Concomitant medical products: unknown part/lot; distal humeral body, modular stem, ulna, unknown srs ic segment.Reported event was confirmed due to patient x-rays 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 could not be determined with information available.Patient x-rays were received and reviewed.Lucency, bone fragments identified and suggestion of osteolysis can be identified as contributing factors for the continual issues of pain and adl difficulty.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.This report is being submitted late as it has been identified in remediation.Not returned to manufacturer.
|