(b)(4).Reported event was confirmed by review of medical records.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.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: 0001825034-2018-06650, 0001825034-2018-06651, 0001825034-2018-06652, 0001825034-2018-06653.
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It was reported that the patient presented approximately one week status post total hip arthroplasty with continued ongoing drainage from a small site along her incision, erythema surrounding the wound, and some tenderness.Patient underwent incision and drainage of the wound.
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