(b)(4).Concomitant medical devices ¿ orthopedic salvage system modular tibial baseplate 67mm, catalog #: 15042,1 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 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, 0001825034-2019-00699, 0001825034-2019-00700, 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.Device evaluated by mfr? investigation incomplete.
|