M-VIZION FEMORAL REVISION SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO DETAILED INVESTIGATION COULD BE COMPLETED. WE ARE CURRENTLY ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION TO ENABLE A MORE COMPREHENSIVE INVESTIGATION.

Description of Event or Problem

THE PATIENT UNDERWENT REVISION SURGERY BECAUSE REALIGNMENT OF THE PROXIMAL BODY WAS REQUIRED. INITIALLY, ONLY AN EXCHANGE OF THE PROXIMAL BODY HAD BEEN PLANNED. HOWEVER, SEPARATION OF THE PROXIMAL AND DISTAL BODIES WAS NOT POSSIBLE. CONSEQUENTLY, THE SURGEON HAD TO EXPLANT THE ENTIRE M-VIZION SYSTEM AND IMPLANT A NEW M-VIZION CONSTRUCT. PRIMARY SURGERY DATE UNKNOWN.