(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01073.Device product code - phx.Concomitant medical products: part# 00434901613; lot# 64141291.Part# 00434901500; lot# unk.Part# 00434904011; lot# unk.Part# unk stem; lot# unk.Part# unk screw; lot# unk.Part# unk screw; lot# unk.(b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: poly had disassociated from the tray.Axillary nerve was encased in scar tissue and being pulled with rom of the shoulder.Complete release of the axillary nerve was performed freeing up the nerve, completing axillary nerve decompression.Release of the subscapularis, capslotomy off the inferior glenoid neck.Removal of the glenosphere which was severely scratched.Subscapularis tendon transfer to greater turberosity.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is abnormal alignment with subluxation/dislocation of the reverse type left shoulder arthroplasty with slight proximal and lateral position of the humeral tray in relation to the glenosphere.No fracture is identified.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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It was reported that a patient underwent an initial procedure approximately 1 year and 4 months ago.Subsequently, the patient was revised approximately 1 month post-implantation due to pain and discomfort.During surgery, it was discovered that the poly had disassociated from the humeral tray and the glenosphere was severely scratched.Attempts have been made and no further information has been provided.
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