SHOULDER SYSTEM

Description of Event or Problem

AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON CONFIRMED NO GLENOID FRACTURE WAS PRESENT. THE SURGEON REVISED THE METAPHYSIS, GLENOSPHERE AND THE LINER D 36/+3MM TO A CONSTRAINED E-CROSS LINER D 39/+0. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 APRIL 2026 REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XD 24.5 (K193175) LOT 2501778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APRIL-2025. EXPIRATION DATE: 2030-04-02. 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 04.01.0120 HUMERAL REVERSE HC LINER D 36/+3MM (K170452) LOT 2314161: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2023. EXPIRATION DATE: 2028-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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 INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.