VERSAFITCUP CC TRIO ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 17 JUNE 2026 CUP: VERSAFITCUP CC TRIO 01.26.45.0048 VERSAFITCUP METALBACK CC TRIO D 48 MM (K103352) LOT 2523812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-DEC-2025. EXPIRATION DATE: 23-NOV-2030. 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. CLINICAL EVALUATION A TECHNICAL ERROR OCCURRED DURING PRIMARY CEMENTLESS THA, THAT LED TO A WRONG POSITION OF THE ACETABULAR CUP. THE PATIENT WAS REOPERATED AFTER FEW WEEKS AND AN ACATBULAR CAGE WITH A CEMENTED-IN PE CUP WAS PLACED IN THE ACETABULUM. THE FEMORAL COMPONENT WAS CORRECTLY IMPLANTED AND WELL FIXED AND IT WAS LEFT IN PLACE. NO MALFUNCTION OR DEFECT OF ANY IMPLANTED DEVICE. ROOT CAUSE: BASED ON THE AVAILABLE CLINICAL INFORMATION, THE REVISION WAS REQUIRED DUE TO INCORRECT POSITIONING OF THE ACETABULAR CUP DURING THE PRIMARY SURGERY, WHICH SUBSEQUENTLY LED TO CUP LOOSENING. THE EVENT IS THEREFORE CONSIDERED RELATED TO AN APPLICATION-SPECIFIC TECHNICAL ERROR DURING IMPLANTATION. THERE IS NO INDICATION THAT ANY MALFUNCTION OR DEFECT OF THE IMPLANTED DEVICES CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2026. ON (B)(6) 2026, REVISION SURGERY WAS PERFORMED ON THE LEFT SIDE. ACCORDING TO THE SURGEON, THE REVISION WAS REQUIRED DUE TO INCORRECT POSITIONING OF THE ACETABULAR IMPLANT DURING THE PRIMARY SURGERY, WITH SUBSEQUENT IMPLANT LOOSENING. NO LOOSENING OF THE FEMORAL STEM AND NO INFECTION WERE REPORTED. ALL COMPONENTS WERE EXPLANTED, EXCEPT FOR THE MINIMAX STEM. REIMPLANTATION WAS PERFORMED USING A REINFORCEMENT CAGE, AN APRICOT 44, AND A CRCO BALL HEAD 32 M.