(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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.Concomitant medical products: item # unk, stem, lot # unk, item # unk, head, lot # unk, item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04936, 0001825034-2018-04938, 0001825034-2018-04941.
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It was reported that approximately 2 weeks post implantation, patient had presented with bloody, yellow drainage from mild distal incision.Patient was thus admitted for observation and treated with iv antibiotics.Subsequently, patient underwent irrigation and debridement due to non-healing surgical wound.Attempts have been made, and no further information has been provided.
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