Pending evaluation.Concomitant medical device(s): 300-30-06 - equinoxe preserve stem 6mm, (b)(4), 320-06-42 - glenosphere 42mm, (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(4), 320-15-05 - eq rev locking screw, (b)(4), 320-20-00 - eq reverse torque defining screw kit, (b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(4), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, (b)(4), 320-42-03 - equinoxe reverse 42mm humeral liner +2.5, (b)(4), 320-15-01 - eq rev glenoid plate, (b)(4).
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Section h10: (h3) the revision reported was likely the result of the glenoid baseplate not achieving long-term fixation, causing the compression screws to bear the joint load and eventually fracture.However, this cannot be confirmed as the devices were not returned for evaluation and adequate information was not provided to determine the root cause of the insufficient glenoid baseplate fixation.
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