SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 30 JUNE 2026 REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER D 39/+3MM (K170452) LOT 2112133: 90 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 27-SEP-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 88 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XD 24.5 (K193175) LOT 2115876: 38 ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2022. EXPIRATION DATE: 27-FEB-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2110702: 377 ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2022. EXPIRATION DATE: 01-FEB-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 377 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE AVAILABLE INFORMATION, THE REPORTED INSTABILITY MAY BE RELATED TO SOFT TISSUE LAXITY, WHICH IS A KNOWN POSSIBLE COMPLICATION FOLLOWING TSA, AS SOFT TISSUES MAY STRETCH OVER TIME AND PROVIDE INSUFFICIENT STABILITY. NO EVIDENCE OF DEVICE MALFUNCTION WAS IDENTIFIED, AND THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES.

Description of Event or Problem

THE PATIENT HAD PRIMARY LEFT SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE THAT WAS SUSTAINED WHILE THE PATIENT WAS SLEEPING. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR 2022-00683). PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE GLENOSPHERE FROM 39XD 24.5 TO 42XD 24.5, THE METAPHYSIS +0MM/0° TO A SAME SIZE METAPHYSIS AND THE HUMERAL REVERSE HC LINER D 39/+3MM TO A HUM. REV. CONSTRAINED E-CROSS LINER D 42/+3. THE SURGERY WAS COMPLETED SUCCESSFULLY.