BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CFE LATER. TAPERLOC.

    MDR report key: 52899 · Received November 27, 1996

    Report

    Report Number
    1825034-1996-00037
    Event Type
    Injury
    Date Received
    November 27, 1996
    Date of Event
    October 1, 1996
    Report Date
    November 26, 1996
    Manufacturer
    BIOMET, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FEMORAL COMPONENT WAS IMPLANTED ON 1/23/90. REVISION SURGERY WAS PERFORMED ON 10/30/96, DUE TO FRACTURE OF STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CFE LATER. TAPERLOC. Implant PROTHESIS, HIP, COMP. KWY BIOMET, INC. NA 427300

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R