(b)(4).D10 - medical product: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 263010, catalog #: 110032410, comp aug mini bsplt w tpr s, lot # 64314041, catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 606680, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 504390, 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, and 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, 0001825034-2023-02030, 0001825034-2023-02031, 0001825034-2023-02032, 0001825034-2023-02033, 0001825034-2023-02034, and 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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