(b)(4).Concomitant medical products: unknown zimmer cpt stem, unknown liner, unknown cup.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01055.
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It was reported patient underwent stage ii procedure.Approximately 5 years later, patient started experiencing elevated metal ions, issues with mood, memory and sleep disturbances.No revision has been reported to date.No further event information available at the time of this report.
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