(b)(4).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # unk, shell, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04971, 0001825034 - 2018 - 04972, 0001825034 - 2018 - 04973.
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It was reported that approximately 6 weeks post implantation, the patient had presented with dehiscence to the distal portion of the wound, about 1 cm long, and serous fluid.Subsequently, patient was revised due to concern that they were having a suture reaction.Revision was due to non-healing wound, due to suture reaction, no implants were explanted or implanted during this procedure.Attempts were made and no further information has been provided.
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