ALLIANCE®

Description of Event or Problem

PATIENT UNDERWENT LEFT SHOULDER ARTHROPLASTY. POST-OP X-RAY SHOWED A SMALL METAL OBJECT, WHICH WAS FOUND TO BE A SMALL PIECE FROM THE BIOMET INSTRUMENT SET USED TO PLACE THE SHOULDER ARTHROPLASTY. IT WAS FELT THAT THIS OBJECT WOULD NOT CAUSE THE PATIENT ANY ISSUES, AND IT WAS NOT NECESSARY TO REMOVE IT. AFTER DISCUSSION OF THE RISKS AND BENEFITS, THE PATIENT CHOSE TO HAVE IT REMOVED. HE RETURNED TO SURGERY AND THE FOREIGN BODY WAS FOUND BETWEEN THE PECTORALIS AND THE DELTOID. IT WAS REMOVED WITHOUT DIFFICULTY. REMOVAL WAS VERIFIED WITH FLUOROSCOPY. GLENOID SIZER HANDLE, PART # SBGL2000 WAS THE PART THAT BROKE, ZIMMER WAS MADE AWARE, AND THEY CURRENTLY HAVE THE DEVICE FOR INVESTIGATION. MANUFACTURER RESPONSE FOR PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED, ALLIANCE® (PER SITE REPORTER). ZIMMER IS CURRENTLY INVESTIGATING. NO FINDINGS AS OF THIS REPORT.