(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00086, and 0002648920-2020-00179.Concomitant medical products: articular surface medial congruent (mc) left 10 mm height, catalog#: 42512100410, lot#: 64164251.All poly patella cemented 32 mm diameter, catalog#: 42540000032, lot#: 64181002.Natural tibia trabecular metal two-peg porous fixed bearing left size d, catalog#: 42530006701, lot#: 64050819.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that patient underwent a left total knee arthroplasty.Subsequently, she had a closed manipulation at approximately 4 weeks postop and a closed manipulation under anesthesia (mua) approximately three months later, with hospital admission for aggressive pt and continuous cpm due to ongoing postoperative arthrofibrosis and limited rom.The outcome remains pending.
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No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: at six-month post op patient had flexion 94/extension 6 and underwent closed manipulation.Radiographs show no evidence of gaps between bone/ implant interface.Approximately four months¿ post op patient had range of motion from 12-56 and underwent mua.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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.
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