(b)(4).D10 - medical product: catalog#: 115310, comp rvrs shldr glnsp std 36mm, lot#: 670930.Catalog#: 118001, versa-dial/comp ti std taper, lot#: 411920.Catalog#: 180553, comp lk scr 3.5hex 4.75x30 st, lot#: 541780.Catalog#: 180553, comp lk scr 3.5hex 4.75x30 st, lot#: 472190.Catalog#: 180552, comp lk scr 3.5hex 4.75x25 st, lot#: 593030.Catalog#: 115397, comp rvs cntrl 6.5x35mm st/rst, lot#: 172790.Catalog#: 180561, comp nlk scr 3.5hex 4.75x35 st, lot#: 251830.Catalog#: 180560, comp nlk scr 3.5hex 4.75x30 st, lot#: 541780.Catalog#: 113653, comp primary stem 13mm std, lot#: 921870.Catalog#: 115370, comp rvs tray co 44mm, lot#: 577900.Catalog#: xl-115363, arcom xl 44-36 std hmrl brng, lot#: 355910.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001825034-2024-00955, 0001825034-2024-00957.H3 other text: product location unknown.
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It was reported patient underwent left reverse total shoulder approximately 8 years ago.Subsequently about a year later the patient underwent a revision due to bone erosion (notching) ho, and poor baseplate positioning.The patient retained the well fixed stem, but revised humeral tray & bearing.Glenosphere components revised to competitor products.No further information is known.
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