(b)(4).Medical products: item#: 110031426, cr vivacit-e 36mm brng +3 ret; lot#: 64525929, item#: 110031400, mini tray +5mm cocr +0 offset; lot#: 65312082, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 651310, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 728930, item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 762870, item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: j7192927.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implant disassembly with separation of the glenosphere from the base plate.No signs of loosening, wear, radiolucency, or contributing factors.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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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