BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL 2 TOTAL WRIST IMPLANT

    MDR report key: 481387 · Received August 22, 2003

    Report

    Report Number
    MW1029402
    Event Type
    Injury
    Date Received
    August 22, 2003
    Date of Event
    August 11, 2003
    Report Date
    August 22, 2003
    Manufacturer
    KMI, INC.
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BREAKAGE OF CARPAL COMPONENT OF UNIVERSAL 2 TOTAL WRIST IMPLANT. IMPLANT FRACTURE THROUGH THE CARPAL COMPONENT STEM. WAS NOTED APPROXIMATELY ONE YEAR POST OP FOR THE FIRST TIME, BUT MAY HAVE BEEN PRESENT EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL 2 TOTAL WRIST IMPLANT TOTAL WRIST IMPLANT KWM KMI, INC. UNIVERSAL 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention