(b)(4).Concomitant medical products: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot #: 670930; catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot #: 415440; 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, 0001825034-2024-00956.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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