UNIVERS APEX OPTIFIT HUMERAL STEM, 6MM

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 20-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9100-06M UNIVERS APEX OPTIFIT HUMERAL STEM (6 MM) HAD AN INFERIOR SCREW THAT WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 26-MAY-2026: DURING A REVISION TOTAL SHOULDER ARTHROPLASTY TO HEMIARTHROPLASTY, WHILE IMPLANTING THE AR-9100-06M UNIVERS APEX OPTIFIT HUMERAL STEM (6 MM), THE INFERIOR SCREW EXHIBITED AN ISSUE DESCRIBED INTRAOPERATIVELY AS ¿SPINNING¿ WHEN ENGAGED WITH THE DRIVER. THE IMPLANT WAS REMOVED FROM THE PATIENT, AND FURTHER EVALUATION ON THE BACK TABLE CONFIRMED THE SCREW WOULD NOT ENGAGE OR SPIN. THE DRIVER FUNCTIONED AS INTENDED WHEN TESTED WITH THE SUPERIOR SCREW. THE AFFECTED IMPLANT WAS EXPLANTED AND REPLACED WITH AN AR-9100-07M UNIVERS APEX OPTIFIT HUMERAL STEM (7MM STEM) TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: THE SURGERY WAS A REVISION PROCEDURE PERFORMED DUE TO AN ISSUE WITH A PREVIOUSLY IMPLANTED NON ARTHREX DEVICE.