(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 - 2018 - 00061, 0001822565 - 2018 - 00062.Product has been discarded.
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Reported event was confirmed by review of photos, which showed both devices are fractured into two pieces on the medial side.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no trends were identified.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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