(b)(4).Udi #: (b)(4).Concomitant medical devices: 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 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 rs 7cm modular segmented femoral component right catalog #: 161011 lot #: 306670, 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, 0001825034-2019-00700, 0001825034-2019-00701, 0001825034-2019-00702, 0001825034-2019-00703, 0001825034-2019-00704, 0001825034-2019-00705, 0001825034-2019-00706, 0001825034-2019-00707, 0001825034-2019-00708, 0001825034-2019-00709, 0001825034-2019-00710.Investigation incomplete.
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