SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 17 JUNE 2026 REVERSE SHOULDER SYSTEM 04.01.0401 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 15° (K231911) LOT 2339043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2024. EXPIRATION DATE: 2029-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0125 HUMERAL REVERSE HC LINER D 42/+0MM (K170452) LOT. 2503809: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2025. EXPIRATION DATE: 2030-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0280 SENSITIN LAT. GLENOSPHERE 42XD 24.5 (K203755) LOT. 2429761: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2025. EXPIRATION DATE: 2030-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

Description of Event or Problem

AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND THE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.