(b)(4).Medical devices: 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 - 05077, 0001825034 - 2018 - 05078, 0001825034 - 2018 - 05080.Reported event was confirmed due to medical record review 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.Not returned to manufacturer.
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It was reported that approximately 4-6 weeks post implantation, the patient had presented with non-healing necrosis in the fold of the pannus.Local wound care was attempted.Due to the location and depth, the patient underwent a wound revision.Attempts have been made and no further information has been provided.
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