PROFEMUR® MODULAR FEMORAL NECK

Description of Event or Problem

ALLEGEDLY, AFTER THE INITIAL SURGERY ON (B)(6), THE PATIENT UNDERWENT REHABILITATION INCLUDING GAIT TRAINING, BUT COMPLAINED OF PAIN AND HAD DIFFICULTY WALKING, SO AN X-RAY CONFIRMED DISLOCATION. THE PATIENT WAS ABLE TO MANUALLY REPAIR THE DISLOCATION, BUT LATER DISLOCATED AGAIN, SO A REVISION OPERATION WAS PERFORMED TO REPLACE THE NECK, HEAD, AND BIPOLAR CUP, AND THE PATIENT HAS BEEN STABLE SINCE THEN. DOCTOR'S FINDING: THE PATIENT HAD UNDERGONE REHABILITATION AFTER THE INITIAL OPERATION, BUT REPEATED DISLOCATIONS OCCURRED, SO A REVISION OPERATION WAS PERFORMED. WE WOULD LIKE TO REQUEST AN INVESTIGATION TO SEE IF THE DISLOCATION COULD HAVE BEEN CAUSED BY THE PRODUCT. JAPAN-OC00000588.

Additional Manufacturer Narrative

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