As reported, approximately 21 months after the initial right tsa, this (b)(6) y/o female patient, was scheduled for a revision due to scapular notching and dislocation.During the revision the 38 +0 humeral liner was exchanged for a 42 +2.5.However, because the screw had been partially unscrewed the surgeon had to burr out the back of the poly so that it would seat into the tray.Approximately 30-45 mins was added to the case time to resolve the issue.The device will not be returned as it is implanted in the patient.Patient was last known to be in stable condition following the event.This event happened during a revision which is being captured under (b)(4).
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The stripped screw reported was likely the result of the torque defining screw becoming stripped with the humeral stem, preventing the screw from being disassembled.However, this cannot be confirmed because the component was not returned for evaluation as it remained implanted.
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