It was reported patient underwent a comprehensive reverse shoulder arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to infection.The humeral bearing, humeral tray, glenosphere and baseplate were removed and replaced.During the procedure, the humeral bearing would not seat onto the humeral tray.Another humeral bearing and humeral tray were utilized to complete the procedure.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative infection and/or allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2014-07463 / 07466).
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