ARTHREX ECLIPSE HUMERAL HEAD, 39/18

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 04-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT A REVISION FROM ECLIPSE + VAULTLOCK TSA TO RTSA ON (B)(6) 2026. THE PATIENT¿S ORIGINAL SURGERY DATE WAS (B)(6) 2024. THE REVISION WAS PERFORMED DUE TO SUBSCAPULARIS FAILURE AND NOT DUE TO FAILURE OF THE ECLIPSE OR VAULTLOCK IMPLANTS. HOWEVER, SIGNIFICANT VAULTLOCK EROSION WAS NOTED AT LESS THAN TWO YEARS POST-IMPLANTATION. THE ARTHREX IMPLANTS EXPLANTED DURING THE REVISION INCLUDED: AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, SMALL, AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM), AR-9301-39CPC ARTHREX ECLIPSE TRUNION 39 MM, SLOTTED, TPS CAP, AND AN AR-9339-18 ARTHREX ECLIPSE HUMERAL HEAD, 39/18. ADDITIONAL INFORMATION WAS RECEIVED ON 10-MAR-2026: THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2024 FOR A SUBSCAPULARIS TEAR SUSTAINED DURING A PHYSICAL ALTERCATION. DURING THE REVISION, ANTERIOR EROSION MEASURING APPROXIMATELY 2¿3 MM WAS OBSERVED. THE SURGEON DID NOT COMMENT ON WHETHER THE EROSION CONTRIBUTED TO THE NEED FOR REVISION OR IF IT WAS AN INCIDENTAL FINDING. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REPORTED. NO FURTHER SURGERIES ARE ANTICIPATED. THE PATIENT WAS DESCRIBED AS STABLE IMMEDIATELY FOLLOWING THE REVISION PROCEDURE; POSTOPERATIVE STATUS BEYOND LEAVING THE ROOM IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 16-MAR-2026: THE ARTHREX IMPLANT AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM WAS EXPLANTED DURING THE REVISION.