SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 20 JULY 2026 REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE - D 39X24.5 (K170452) LOT 2527747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2026. EXPIRATION DATE: 26-JAN-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 04.01.0481 HUMERAL REVERSE E-CROSS LINER D 39/+0MM (K250338) LOT 2502176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2025. EXPIRATION DATE: 24-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0185 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12 (K180089) LOT 2532060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2026. EXPIRATION DATE: 27-JAN-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. ROOT CAUSE: ASEPTIC LOOSENING AND IMPLANT DISLOCATION ARE POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENTS AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE AND LINER AND THE CAUSE IS UNKNOWN.THE SURGEON REVISED THE GLENOSPHERE TO A LAT. GLENOSPHERE 39 X D 24.5 AND THE HUMERAL REVERSE E-CROSS LINER D 39/+0 MM TO A HUM. REV. CONSTRAINED E-CROSS LINER D 39/+3 MM. DURING THE REVISION PROCEDURE, THE HUMERAL STEM WAS FOUND TO BE LOOSE AND WAS REVISED FROM A SHORT CEMENTLESS HUMERAL DIAPHYSIS SIZE 12 TO A STANDARD CEMENTLESS HUMERAL DIAPHYSIS SIZE 13. THE SURGERY WAS COMPLETED SUCCESSFULLY.