(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products.42512100914, persona art surface mc left 14mm lot# 63841871.42532007901, persona natural tibia cemented 5 deg stemmed left sz g, lot# 63717624.42540000041, persona all poly patella cemented 41mm dia 10mm, lot# 63716234.00111214001, palacos r 1x40, single lot# 86934602.00111214001, palacos r 1x40, single lot# 86934602.
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It was reported a patient had an initial left total knee arthroplasty followed by a i&d with poly exchange about one month post implantation for infection.Subsequently, the patient began to experience persistent pain and swelling and upon assessment was diagnosed with mechanical loosening.Two years, five months after the i&d revision the patient underwent a revision due to aseptic failure.During the revision, encountered synovitis, pitting to the poly from third body wear, and defects noted on the femoral and tibial components.All components were revised without complication.
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