SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JULY 2026 REVERSE SHOULDER SYSTEM 04.01.0206 LAT. GLENOSPHERE 32XD 24.5 (K193175) LOT: 2520890: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2025. EXPIRATION DATE: 19-OCT-2030. 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 04.01.0488 HUM. REV. E-CROSS LINER D 32/+3 - SMALL (K250644) LOT: 2509197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2025. EXPIRATION DATE: 15-APR-2030. 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 AVAILABLE INFORMATION, THE REPORTED INSTABILITY MAY BE RELATED TO SOFT TISSUE LAXITY, WHICH IS A KNOWN POSSIBLE COMPLICATION FOLLOWING TSA, AS SOFT TISSUES MAY STRETCH OVER TIME AND PROVIDE INSUFFICIENT STABILITY. NO EVIDENCE OF DEVICE MALFUNCTION WAS IDENTIFIED, AND THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES.

Description of Event or Problem

REVISION SURGERY DUE TO INSTABILITY AFTER ABOUT 1 MONTHS FROM PRIMARY. THE SURGEON REVISED THE D 32/+3 SMALL REVERSE LINER TO A D 36/+6 SMALL REVERSE LINER AND REVISED THE 32XD 24.5 GLENOSPHERE TO A 36XD 24.5 GLENOSPHERE.