SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JULY 2026 REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER D 36/+6MM (K170452) LOT. 2317081: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2023. EXPIRATION DATE: 06-NOV-2028. 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. REVERSE SHOULDER SYSTEM 04.01.0210 LAT. GLENOSPHERE 36XD 27 (K193175) LOT. 2008830A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUL-2021. EXPIRATION DATE: 01-JUL-2027. 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:DISLOCATION IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT 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

REVISION SURGERY DUE TO JOINT LUXATION BETWEEN LINER AND GLENOSPHERE AFTER ABOUT 2 MONTHS FROM FIRST REVISION SURGERY.THE PATIENT HAD PRIMARY RIGHT REVERSE SHOULDER SURGERY ON (B)(6) 2023.THE SURGEON REVISED THE LINER TO A CONSTRAINED AND THE REVERSE METAPHYSIS.