VERSAFITCUP CC TRIO ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JULY 2026 01.26.45.0042 VERSAFITCUP METALBACK CC TRIO D 42 MM (K122911) LOT. 2314893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 NOVEMBER 2023. EXPIRATION DATE: 13 NOVEMBER 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. VISUAL INSPECTION VISUAL INSPECTION PERFORMED ON 6 JULY 2026. NO EVIDENT SIGNS OR DEFECTS WERE NOTICED; THE LINER WAS STILL INSIDE THE SHELL, WHILE THE COATING APPEARED TOTALLY ABSORBED. FROM THE RECEIVED INFORMATION AND COMPONENTS, THE ROOT CAUSE OF THE EVENT IS UNKNOWN BUT THERE IS NO EVIDENCE OF A FAILURE DEVICE. CLINICAL EVALUATION A FEW MONTHS AFTER PRIMARY CEMENTLESS THA, THE CUP MIGRATES DECISIVELY IN THE CRANIAL-MEDIAL DIRECTION. THE POST-PRIMARY XRAYS WERE NOT SUPPLIED, SO WE CANNOT TELL IF THE MEDIAL WALL OF THE ACETABULUM HAD BEEN VIOLATED AT INDEX SURGERY, BUT THIS IS RATHER POSSIBLE. WITH NO PRIMARY STABILITY ACHIEVED, THE CUP COULD NEVER BE STABLE AND NEVER STARTED THE OSSEOINTEGRATION PHASE. THIS IS NOT DUE TO A DEVICE DEFECT OR MALFUNCTION. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, THE CUP LOOSENING APPEARS RELATED TO LACK OF PRIMARY STABILITY AFTER THE INDEX SURGERY, PREVENTING PROPER OSSEOINTEGRATION. ALTHOUGH THIS CANNOT BE CONFIRMED WITHOUT POST-PRIMARY X-RAYS, POSSIBLE MEDIAL ACETABULAR WALL VIOLATION CANNOT BE EXCLUDED. THE BATCH REVIEW AND VISUAL INSPECTION DID NOT INDICATE ANY RELATED MANUFACTURING ISSUE, DEVICE DEFECT, OR MALFUNCTION.

Description of Event or Problem

REVISION SURGERY AFTER 6 MONTHS FROM PRIMARY SURGERY DUE TO THE LOOSENING OF THE CUP. THE SURGERY WAS SUCCESSFULLY COMPLETED.