GLENOID RECONSTRUCTION SYSTEM

Description of Event or Problem

REVISION SURGERY DUE TO INSTABILITY CAUSED BY IMPLANT LOOSENING AND COMPLETE FAILURE OF THE GLENOID BASEPLATE AFTER ABOUT 2 YEARS AND 2 MONTHS FROM PRIMARY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA GLENOID COMPONENTS TO A COMPETITOR CUSTOM GLENOID. DUE TO THE MEDACTA STEM BEING WELL FIXED, IT REMAINED IMPLANTED.

Additional Manufacturer Narrative

CLINICAL EVALUATION THE PATIENT PRESENTED WITH INSTABILITY TWO YEARS AND TWO MONTHS AFTER PRIMARY SURGERY, SECONDARY TO BASEPLATE LOOSENING AND COMPLETE GLENOID BASEPLATE MOBILIZATION, WITH NO REPORTED TRAUMA. NO INFORMATION IS AVAILABLE REGARDING THE CLINICAL COURSE OVER THE FIRST TWO YEARS. NO BONE GRAFT WAS USED AT PRIMARY SURGERY AND THE BASEPLATE WAS SECURED WITH 3 SCREWS. THE PATIENT WAS 75 YEARS OLD WITH REPORTEDLY DECENT BONE QUALITY, AND THE GLENOSPHERE WAS PROPERLY SEATED (NOT UNSCREWED). THE AVAILABLE RADIOGRAPHIC IMAGES REVEAL NOTHING OF RELEVANCE. THE FINDINGS ARE CONSISTENT WITH ASEPTIC LOOSENING, A RECOGNIZED ADVERSE EVENT OF SHOULDER ARTHROPLASTY WHOSE CAUSE FREQUENTLY CANNOT BE DETERMINED. AN ADDITIONAL POSSIBLE MECHANISM IS HUMERAL IMPINGEMENT AGAINST THE GLENOSPHERE, WHEREBY THE HUMERAL COMPONENT ACTS AS A FULCRUM AND PROGRESSIVELY LEVERS THE GLENOSPHERE, TRANSMITTING LOOSENING FORCES TO THE BASEPLATE. NO DEVICE DEFICIENCY HAS BEEN IDENTIFIED. THE INVESTIGATION IDENTIFIES NO ROOT CAUSE ATTRIBUTABLE TO THE DEVICE. BATCH REVIEW PERFORMED ON 13 JULY 2026 LOT 2308500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2024. EXPIRATION DATE: 18-DEC-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 104 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE EVENT IS CONSISTENT WITH ASEPTIC LOOSENING OF THE GLENOID BASEPLATE AND MAY HAVE BEEN INFLUENCED BY CASE-SPECIFIC CLINICAL OR MECHANICAL FACTORS; HOWEVER, THE AVAILABLE INFORMATION IS INSUFFICIENT TO CONFIRM ANY SPECIFIC CONTRIBUTING MECHANISM. THE BATCH REVIEW DID NOT IDENTIFY ANY POTENTIALLY RELATED MANUFACTURING ISSUE. THE INVESTIGATION IDENTIFIES NO ROOT CAUSE ATTRIBUTABLE TO THE DEVICE.