(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 42502606601 persona femoral cemented cr std left sz 9 lot# 63681226 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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