SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 18 JUNE 2026 REVERSE SHOULDER SYSTEM 04.01.0125 HUMERAL REVERSE HC LINER D 42/+0MM (K170452) LOT 2516270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2025. EXPIRATION DATE: 22-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. REVERSE SHOULDER SYSTEM 04.01.0280 SENSITIN LAT. GLENOSPHERE 42XD 24.5 (K203755) LOT 2426207: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2025. EXPIRATION DATE: 02-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: 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

THE PATIENT HAD PRIMARY LEFT REVERSE SHOULDER SURGERY ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 42/+0MM REVERSE HC LINER WITH A SAME SIZE LINER. DURING THE PROCEDURE THE SURGEON ALSO REMOVED THE GLENOSPHERE AND REATTACHED IT WITH NEW GLENOSPHERE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY ON (B)(6) 2026, THE PATIENT RETURNED DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HUMERAL REVERSE HC LINER D 42/+0MM TO A CONSTRAINED E-CROSS LINER D 42/+0, AND REVISED THE SENSITIN LAT. GLENOSPHERE 42XD 24.5 TO A SAME SIZE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.