(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-01862, 0001825034-2022-01863, 0001825034-2022-01864, 0001825034-2022-01866, 0001825034-2022-01867.Concomitant medical products: oss rs axle item# 161035 lot# 821880, oss poly lock pin item# 150478 lot# 289470, oss rs poly fem bushings set/2 item# 161034 lot# 838700, oss tibial poly bearing 20mm item# 150414 lot# 351350, oss reinforced yoke item# 150493 lot# 529730, oss tib block 20x63/67 ml/lr item# 150430 lot# 246240, oss tib blk aug 10x63/67 univ item# 150426 lot# 626690, cps anchor plug 14mm item# 178404 lot# 136710, cps transverse pin 6pk 36mm item# 178528 lot# 889380, cps sm m-h f spindle 12mm pcha item# 178472 lot# 240530, cps nut co-cr-mo alloy item# 178512 lot# 485340, cps/oss 5cm tpr adapt w/oss sc item# 178711 lot# 821510, oss rs 7 cm mod seg fmrl-lt item# 161012 lot# 547240, cps centering sleeve 16mm item# 178538 lot# 818860, cobalt mv bone cement 40gm b item# 402439 lot# 187910.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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