PROFEMUR® MODULAR FEMORAL NECK

Description of Event or Problem

ALLEGEDLY, THE DATE OF FIRST OPERATION IS TENTATIVELY SET BECAUSE THE INSERTION DATE IS UNKNOWN. THE LOT IS ALSO TENTATIVELY SET BECAUSE THE LOT IS ALSO UNKNOWN. WHEN REV-THA WAS PERFORMED AT ENDA ARTHROPLASTY CENTER DUE TO DEFECTIVE CUP PLACEMENT AND BFH AND NECK WERE REMOVED. WHEN THE JUNCTION BETWEEN THE BFH AND THE NECK WAS REMOVED, IT WAS FOUND TO BE IN A BLACKISH METALLOSIS-LIKE STATE. THERE WAS NO SUCH REACTION ON THE SLIDING SURFACE WITH THE CUP, AND THE REACTION WAS OBSERVED ONLY IN THE AREA MENTIONED ABOVE. ALTHOUGH THERE IS NO EVIDENCE OF PATIENT EFFECTS, WE ANTICIPATE THAT SIMILAR CASES MAY OCCUR IN THE FUTURE WHEN CONSERVE IS REMOVED, SO WE NEED TO REPORT TO PHYSICIANS, INCLUDING PAST CASES. (B)(4).

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.