BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP PROSTHESIS

    MDR report key: 33364 · Received June 11, 1996

    Report

    Report Number
    MW1009268
    Event Type
    Malfunction
    Date Received
    June 11, 1996
    Date of Event
    July 1, 1995
    Report Date
    June 10, 1996
    Manufacturer
    INTERMEDICS ORTHOPEDICS, INC.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR EXPERIENCED PAIN WHICH RADIATED FROM HER HIP DOWN TO HER ANKLE. THIS SITUATION MADE HER UNABLE TO WALK. AS SHE STATED "(IT) FEELS LOOSE AND I HAVE TO WAIT UNTIL (IT) IS ATTACHED SO I CAN WALK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP PROSTHESIS Implant HIP PROSTHESIS KWY INTERMEDICS ORTHOPEDICS, INC. APR2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR