BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KMI

    MDR report key: 1399140 · Received June 3, 2009

    Report

    Report Number
    MW5011301
    Event Type
    Injury
    Date Received
    June 3, 2009
    Date of Event
    April 20, 2009
    Report Date
    June 3, 2009
    Manufacturer
    KMI
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAILED PROSTHETIC TOTAL WRIST REPLACEMENT, RIGHT WRIST. DATES OF USE: 2003 - 2009. DIAGNOSIS OR REASON FOR USE: RHEUMATOID ARTHRITIS - TOTAL WRIST REPLACEMENT. MODEL#: KMI 26 3400 RT, CATALOG #: 26-1400, OTHER #: REF#26-3400-RT. UNIVERSAL TOTAL WRIST IMPANT, UNIVERSAL2 TOTAL WRIST IMPLANT SCREWS: 4.5MM CANCELLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMI WRIST PROSTHESIS KWM KMI 7855-40-7899
    2 KMI WRIST PROSTHESIS KWM KMI 7762D-34R-8153
    3 KMI WRIST PROSTHESIS KWM KMI 7763-14-7830
    4 SCREWS SCREWS HWC KMI
    5 SCREWS SCREWS HWC KMI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability