FLEX-FOOT RE-FLEX VSP

Description of Event or Problem

DEVICE ASSEMBLY - LOWER LIMB EXTERNAL PROSTHETIC LEG ASSEMBLY, COMPRISING A HARD SOCKET WITH LINER, WHICH PT'S RESIDUAL LIMB RESTS IN, ATTACHED TO A PROSTHETIC FOOT. THE FEMALE PYRAMID ATTACHMENT ON THE PROXIMAL END OF PROSTHETIC FOOT, THAT ATTACHES TO A MATING MALE PYRAMID ON THE DISTAL END OF PT'S HARD-SOCKET, BECAME LOOSE. AS THE PT STEPPED DOWN ON THE PROSTHETIC LEG THE FOOT PORTION TWISTED DUE TO THE LOOSE PYRAMID, AND THE PT COMPENSATED FOR THE SUDDEN LOSS OF BALANCE BY USING THEIR REMAINING SOUND LIMB TO BRACE THEMSELVES. HOWEVER, THIS RESULTED IN PT LOSING THEIR BALANCE AND FALLING, SPRAINING THEIR ANKLE ON THEIR SOUND LIMB. WHEN INITIALLY REPORTED TO CO IN 2002 THE INJURY EVENT WAS NOT CONSIDERED SEVERE AND NO MDR WAS FILED. THIS PAST 6/24/2002, THE PT INVOLVED IN THIS INCIDENT NOTIFIED OSSUR DIRECTLY TO ADVISE CO THAT DUE TO THE SPRAINED ANKLE ON PT'S SOUND LIMB PT HAD TO HAVE THEIR SOUND LIMB AMPUTATED. THE PT DID NOT INDICATE TO OSSUR THAT OTHER HEALTH FACTORS CONTRIBUTED TO THE NEED FOR AN AMPUTATION. HOWEVER, AFTER SEVERAL ATTEMPTS, OVER A PERIOD OF WEEKS, CO FINALLY WERE ABLE TO SPEAK WITH THE PT'S PROSTHETISTS AND HE INDICATED THAT THE PT WAS GOING TO NEED THEIR SOUND LIMB AMPUTATED FOR PREEXISTING MEDICAL CONDITIONS. THE PROSTHETISTS INDICATED THAT THE SPRAINED ANKLE ONLY HASTENED THE NEED FOR THE AMPUTATION.