(b)(4).(udi): n/a.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01942.
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(b)(4).Bebernardis da, horneff jg, davis de, ramsey ml, pontes mc, austin ls.Revision total elbow arthroplasty failure rates: the impact of primary arthroplasty failure etiology on subsequent revisions.The journal of shoulder and elbow surgery (2019).Https://doi.Org/10.1016/j.Jse.2019.10.010.Reported event was unable to be confirmed due to limited information 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 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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