(b)(4).Concomitant products: item # unk, stem, lot # unk ; item # unk, liner, lot # unk; item # unk, cup, lot # unk.Reported event was confirmed by review of operative notes.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.
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It was reported that the patient underwent an initial total hip arthroplasty.Subsequently, the patient presented with wound drainage and underwent an incision, drainage, debridement due to non-healing wound approximately 45 days later.The patient was diagnosed with infection and underwent treatment.
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