SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 08 JUNE 2026 REVERSE SHOULDER SYSTEM 04.01.0111 HUMERAL REVERSE METAPHYSIS +9MM/0° (K170452) LOT 2307571A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2023. EXPIRATION DATE: 01-NOV-2028. 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 04.01.0190 THREADED GLENOID BASEPLATE D 24.5X25 (K171058) LOT 2315782:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2024. EXPIRATION DATE: 09-DEC-2028. 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 04.01.0209 LAT. GLENOSPHERE 42XD 24.5 (K193175) LOT 2338991: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024. EXPIRATION DATE: 16-JAN-2029. 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 04.01.0127 HUMERAL REVERSE HC LINER D 42/+6MM (K170452) LOT 2304480: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUNE-2023. EXPIRATION DATE: 21-MAY-2028. 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: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 SURGERY USING COMPETITOR IMPLANTS. ON (B)(6) 2024, THE PATIENT WAS REVISED TO MEDACTA IMPLANTS DUE TO A HUMERAL FRACTURE. THE SURGEON REVISED TO A REVERSE SHOULDER SYSTEM. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON ELECTED TO REMOVE THE BASEPLATE AND CONVERT TO A HEMI TO ALLOW THE PATIENT`S SHOULDER TO HEAL BEFORE DECIDING THE NEXT COURSE OF ACTION. THE SURGEON REVISED THE HUMERAL REVERSE METAPHYSIS +9MM/0° TO A HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°;-6 AND IMPLANTED A DOUBLE ECCENTER AND METAL HUMERAL HEAD D 50. THE SURGERY WAS COMPLETED SUCCESSFULLY.