(b)(4).Concomitant medical devices: item#115370; lot# 666100; comp rvs tray co 44mm; item# xl-115363; lot# 298700; arcom xl 44-36 std hmrl brng; item# 115310; lot# 892640; comp rvrs shldr glnsp std 36mm; item# 12-113558; lot# 224320; compr 8mm hum fract stem pps; item# 115396; lot# 783340; comp rvs cntrl 6.5x30mm st/rst; item# 180552; lot# 527240; comp lk scr 3.5hex 4.75x25 st; item# 180552; lot# 900780; comp lk scr 3.5hex 4.75x25 st; item# 180550; lot# 563630; comp lk scr 3.5hex 4.75x15 st.Foreign: event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03809, 0001825034-2020-03811, 0001825034-2020-03812, 0001825034-2020-03813, 0001825034-2020-03815, 0001825034-2020-03816, 0001825034-2020-03817, 0001825034-2020-03818.Remains implanted.
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It was reported that a patient underwent an initial left reverse shoulder procedure.Subsequently, the patient claims to be experiencing tingling, numbness, loss of range of motion, torn rotator cuff and nerve damage.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
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