SIZE 3 ACCOLADE II 132DEG

Additional Manufacturer Narrative

REPORTED EVENT AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE OF THE FEMUR. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAD A RIGHT PRIMARY THA ON (B)(6) 2025.PATIENT HAD A FEMUR PERI-PROSTHETIC FRACTURE TYPE B2. PATIENT WAS REVISED ON (B)(6) 2025.ONLY FEMORAL COMPONENT AND HEAD WERE REVISED.