SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 1 JULY 2026 REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER D 32/+0MM (K170452) LOT 2402701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2024. EXPIRATION DATE: 14-MAY-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0206 LAT. GLENOSPHERE 32XD 24.5 (K193175) LOT 2236672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 09-NOV-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LAT. GLENOSPHERE 32XD 24.5 TO A LAT. GLENOSPHERE 39XD 24.5 AND REVISED THE REVERSE HC LINER D 32/+0MM TO A CONSTRAINED E-CROSS LINER D 39/+3 TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.