UNK

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 2-JAN-2026, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED PAIN WITH ARM ELEVATION. THE PATIENT PRESENTED TO THE CLINIC WITH PAIN DURING ELEVATION OF THE ARM, AND ROTATOR CUFF ARTHROPATHY WAS SUSPECTED. THE PATIENT IS EXPECTED TO BE SCHEDULED FOR A CONVERSION TO REVERSE SHOULDER ARTHROPLASTY SOON. THE EVENT WAS REPORTED AS UNRELATED TO THE ECLIPSE SYSTEM THAT WAS IMPLANTED ON (B)(6) 2023. THIS EVENT HAS AN ONSET DATE OF 19-NOV-2025. ADDITIONAL INFORMATION WAS RECEIVED ON 6-JAN-2026: THE PART NUMBERS OF THE IMPLANTED PRODUCTS ARE UNKNOWN. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE CLINIC WITH COMPLAINTS OF PAIN AND WEAKNESS. A REVISION SURGERY HAS NOT OCCURRED AND IS NOT CURRENTLY SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED ON 13-APR-2026: DURING A REVISION SURGERY PERFORMED ON (B)(6) 2026, ALL ARTHREX PRODUCTS FROM THE INITIAL PROCEDURE WERE EXPLANTED AND REPLACED. ACCORDING TO THE INFORMATION PROVIDED, NONE OF THE DEVICE COMPONENTS WERE FOUND TO BE LOOSE, DAMAGED, OR MALFUNCTIONING INTRAOPERATIVELY. FOLLOWING THE REVISION PROCEDURE, THE PATIENT WAS REPORTED TO BE DOING AS EXPECTED, WITH NO COMPLICATIONS ASSOCIATED WITH THE REVISION SURGERY. THE IMPLANT PART NUMBERS FROM BOTH THE ORIGINAL AND REVISION PROCEDURES ARE NOT AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT, ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO A PATIENT-SPECIFIC EVENT, INCLUDING UNDERLYING HEALTH CONDITIONS.