SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 03 JULY 2026 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2534564: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2026. EXPIRATION DATE: 02-FEB-2031. 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 04.01.0123 HUMERAL REVERSE HC LINER D 39/+3MM (K170452) LOT 2509663:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2025. EXPIRATION DATE: 004-JUN-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 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

AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. THE SURGEON REVISED THE METAPHYSIS FROM +0 MM/0° TO +9 MM/0° AND REPLACED THE LINER WITH A CONSTRAINED LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.