(b)(4).Concomitant medical product: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 263010 catalog #: 110032410, comp aug mini bsplt w tpr s, lot # 64314041 catalog #: 115370, comp rvs tray co 44mm, lot # 403720 catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 606680 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 427570 catalog #: 113631, comp primary stem 11mm mini, lot # 733660 catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 919910 catalog #: ep-115393, e1 44-36 std hmrl brng, lot # 961790 h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the has been requested but not returned by hospital.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: 0001825034-2023-02027, 0001825034-2023-02028, 0001825034-2023-02029, 0001825034-2023-02030, 0001825034-2023-02032, 0001825034-2023-02033, 0001825034-2023-02034, 0001825034-2023-02041 h3 other text : requested but not returned by hospital.
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It was reported the patient underwent a procedure approximately 4 years ago.Subsequently, the patient was revised about a month ago due to pain, reactive tissue, fluid in the capsule, and tissue between the baseplate and glenosphere.There is possible metallosis or allergy.Attempts have been made and there is no further information at this time.
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