(b)(4).Product code: phx.Concomitant medical products: 115370, comp rvs tray, 987730.Xl-115363, hmrl brng, 083700.115310, comp rvrs shldr glnsp, 036770.115330, comp rvrs shdr glen bsplt, 550170.113651, comp primary stem, 658090.118001, comp ti std taper, 022770.180553, comp lk scr, 3.5hex 586200.180509, comp non-lckng screw, 931620.180503, comp locking screw, 424160.115382, comp rvs cntrl scr, 714480.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product 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 - 2021 - 02436.0001825034 - 2021 - 02437.0001825034 - 2021 - 02438.0001825034 - 2021 - 02439.0001825034 - 2021 - 02440.0001825034 - 2021 - 02441.0001825034 - 2021 - 02442.0001825034 - 2021 - 02443.0001825034 - 2021 - 02445.0001825034 - 2021 - 02446.
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It was reported by patients legal counsel that the patient underwent a left total shoulder arthroplasty revision procedure approximately six (6) years post-implantation due to pain, loss of range of motion, and loosening of the components.Attempts have been made and no further information has been provided.
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