Zimmer biomet complaint number (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.The investigation is in process and once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report(s): 0001825034 - 2018 - 06955; 0001825034 - 2018 - 06972; 0001825034 - 2018 - 06976; 0001825034 - 2018 - 06988.Remains implanted.
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(b)(4).The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Device history record was not reviewed due to item and lot identification is necessary for review.The root cause was unable to be determined as cause of fall is unknown.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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