(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, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04881, 0001825034-2018-04883, 0001825034-2018-04888.
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It was reported that approximately one month post implantation, a patient had presented with fever, severe redness, and drainage from the surgical wound.Radiographs revealed that the components were well-fixed and positioned.Patient thus underwent an incision and drainage with wound closure and application of wound v.A.C on the affected hip due to non-healing and wound infection.A hemovac drain was also placed.Attempts have been made, and no further information has been provided.
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