BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1010-34 AIM FEMORAL NAIL

    MDR report key: 193653 · Received October 23, 1998

    Report

    Report Number
    2020311-1998-00017
    Event Type
    Malfunction
    Date Received
    October 23, 1998
    Date of Event
    January 1, 1998
    Report Date
    September 8, 1998
    Manufacturer
    DEPUY ACE MEDICAL CO.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BONE BROKE. BASED ON INFORMATION FROM PATIENT'S NEIGHBOR. IN 1991, PATIENT WAS IMPLANTED WITH FEMORAL NAIL. NOW, IN 1998, PATIENT NEEDS KNEE REPLACEMENT SURGERY. IN ATTEMPTING TO REMOVE THE NAIL TO MAKE ROOM FOR THE KNEE, THE PATIENT'S HIP BROKE IN 4 PLACES. SHE IS NOW WHEELCHAIR BOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1010-34 AIM FEMORAL NAIL Implant INTRAMEDULLARY NAILS HSB DEPUY ACE MEDICAL CO. NA A220

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR