(b)(4).Medical product: unknown nexgen tibial tray size 8: catalog#ni, lot#ni; unknown nexgen articular surface 10mm: catalog#ni, lot#ni; unknown patella component size 41: catalog#ni, lot#ni; unknown bone cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-03560; 0001822565-2022-03562; 0001822565-2022-03563.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device, a review of the device history records was not performed.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.As was the case here, larger hematomas may need to be surgically evacuated (irrigation and debridement) in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.As such, the root cause of the reported event was determined to be unrelated to the implanted device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, within weeks post-implantation, the patient underwent an irrigation and debridement procedure for a hematoma.The exact event date is unknown.Due diligence is complete as multiple attempts have been made.It was reported that no further information is available.
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