VERSAFITCUP CC TRIO ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 JUNE 2026 01.26.3644HCT FLAT PE HC LINER D 36 / E (K103352) LOT. 153649: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 OCTOBER 2015. EXPIRATION DATE: 05 OCTOBER 2020. 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 INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE OBSERVED LINER WEAR APPEARS CONSISTENT WITH LONG-TERM IN VIVO USE AND MAY BE RELATED TO PATIENT- AND CASE-SPECIFIC FACTORS; HOWEVER, THE PRECISE CONTRIBUTING CONDITIONS CANNOT BE DETERMINED.

Description of Event or Problem

REVISION SURGERY WAS PERFORMED 10 YEARS AND 6 MONTHS AFTER THE PRIMARY PROCEDURE DUE TO GREATER TROCHANTERIC OSTEOLYSIS, WHICH LED TO A FRACTURE. INTRAOPERATIVELY, WEAR OF THE LINER WAS IDENTIFIED, AND THE LINER WAS REPLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED.