BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX-FOOT RE-FLEX VSP

    MDR report key: 419361 · Received September 27, 2002

    Report

    Report Number
    2085446-2002-00001
    Event Type
    Injury
    Date Received
    September 27, 2002
    Date of Event
    March 16, 2002
    Report Date
    September 27, 2002
    Manufacturer
    OSSUR NORTH AMERICA, INC.
    Product Code
    ISH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-FOOT RE-FLEX VSP EXTERNAL, LOWER LIMB, PROSTHETIC FOOT, PYRAMID CONNECTOR ISH OSSUR NORTH AMERICA, INC. RFX09300 FOOT ASSEMBLY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability 2002).| LOWER LIMB PROSTHESIS ASSEMBLY (2001 TO