(b)(4).Concomitant medical products ¿ orthopedic salvage system modular tibial baseplate 67mm catalog #: 150421 lot #: 523710, orthopedic salvage system tibial augment block 10 x 63/67mm catalog #: 150426 lot #: 225600, orthopedic salvage system cemented proximal tibial stem catalog #: 150445 lot #: 751190, orthopedic salvage system 5cm reinforced yolk catalog #: 150493 lot #: 065310, orthopedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 248130, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: 261210, orthopedic salvage system rs axle catalog #: 161035 lot #: 257570, orthopedic salvage system polyethylene locking pin catalog #: 150510 lot #: 211820, orthopedic salvage system cemented im stem 13mm x 225mm catalog #: 150374 lot #: 416160, orthopedic salvage system diaphyseal locking screw set catalog #: 150481 lot #: 583850, orthopedic salvage system 4cm diaphyseal segment catalog #: 150482 lot #: 034700, orthopedic salvage system segmental stacking adapter catalog #: 150483 lot #: 097170, orthopedic salvage system 4cm diaphyseal segment catalog #: 150482 lot #: 899920, orthopedic salvage system polyethylene tibial bearing 16mm catalog #: 150412 lot #: 790410.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it still remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2019-00696; 0001825034-2019-00697; 0001825034-2019-00698; 0001825034-2019-00699; 0001825034-2019-00700; 0001825034-2019-00701; 0001825034-2019-00702; 0001825034-2019-00703; 0001825034-2019-00704; 0001825034-2019-00705; 0001825034-2019-00706; 0001825034-2019-00707; 0001825034-2019-00708; 0001825034-2019-00710.
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