(b)(4).Concomitant medical products: (b)(6) 2020, 150478 oss poly lock pin 104760, 150493 oss reinforced yoke 888420, 888420 oss rs axle 552090, 161034 oss rs poly fem bushings set/2 155730, 150476 oss poly tibial bushing 850230, 161040 oss rs non-mod plt shrt 71 826540, 178512 cps nut co-cr-mo alloy 484110, 178538 cps centering sleeve 16mm 548010, 178351 cps xs spdl with pins 600lbf 498540, 178526 cps transverse pin 6pk 28mm 787280, 178404 cps anchor plug 14mm 332040, 161095 oss rs 14mm ls tibial bearing 729400.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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 the patient underwent a total right oss knee arthroplasty.Approximately 22 months post implantation, there was difficulty during the lengthening process of the oss femur, in which the femur could not be expanded.There has been no revision reported to date.
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