(b)(4).Concomitant medical products: 00840009500, nexel articulation kit size 5/6, 63063250; 00840004610, nexel elbow humeral component, 62903325; 00111914001, palacos lvg 1x40 single, 79924395; 00840108000, elbow torque driver, 56613797; 00840009000, humeral screw kit 2 humeral screws, 63006357; 32810503800, cement restrictor with nozzle 1 - 16 mm diameter 1 - 25 mm diameter, 63064916; 00504905300, disposable bone cement curette, 62971147.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06039, 0001822565 - 2017 - 06659.
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It was reported that the patient underwent a total elbow replacement.Subsequently, the patient has been indicated for a revision surgery due to severe pain and spontaneous, non-trauma-induced fractures of the humerus and ulna around the implanted components.The indicated revision procedure may also involve amputation due to bone and nerve damage.No additional patient consequences were reported.
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.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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