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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(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 #: 115370, comp rvs tray co 44mm, lot # 403720 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 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, 0001825034-2023-02031, 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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(b)(4).Updated: b4, b5, d2, e1, g3, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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