(b)(4).(udi): n/a medical product: catalog #: 118801, versadial comp ti std ta per adaptor, lot # 910150 catalog #: 118801, versadial comp ti std ta per adaptor, lot # 089750.Catalog #: 180501, comp locking screw 4.75x20mm, lot # 609520.Catalog #: 180502, comp locking screw 4.75x25mm, lot # 696450.Catalog #: 180500, comp locking screw 4.75x15mm, lot # 919320.Catalog #: 180509, comp non-lckng screw 4.75x25mm, lot # 552660.Catalog #: xl-115363, arcom xl 44-36 std hmrl brng, lot # 692320.Catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 081870.Catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 283300.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
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It was reported that the patient underwent a shoulder arthroplasty approximately 9 years ago.Subsequently the patient underwent a revision procedure approximately 6 years post-implantation due to loss of mobility, function, and severe pain in the left shoulder and was diagnosed with a trunnion fracture off of the humeral tray.
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It was reported that the patient underwent a shoulder arthroplasty approximately 12 years ago.Subsequently the patient underwent a revision procedure approximately 10 years post-implantation due to loss of mobility, function, and severe pain in the left shoulder and was diagnosed with a trunnion fracture off of the humeral tray.It was further reported the patient was again revised approximately 4 years ago due to pain, dislocation, and limited mobility.During the revision, osteolysis was noted as well as a fracture of the trunnion from the humeral tray.The tray and bearing were replaced without complication.
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