BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEUCE

    MDR report key: 1983623 · Received February 4, 2011

    Report

    Report Number
    MW5019313
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HSX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, PATIENT WITH HISTORY OF DEGENERATIVE JOINT DISEASE OF LEFT KNEE UNDERWENT A DEUCE KNEE RESURFACING OF THE LEFT KNEE. APPROXIMATELY 4-5 MONTHS AGO, PATIENT BECAME EXPERIENCED PROBLEMS WITH LEFT KNEE AND X-RAY WAS OBTAINED AND PATIENT WAS NOTED TO HAVE A FRACTURE OF THE DEUCE TIBIAL COMPONENT. ON (B)(6) 2011, PATIENT UNDERWENT REVISION OF THE DEUCE RESURFACING OF THE LEFT AND REMOVAL OF THE DEUCE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEUCE TIBIAL BASEPLATE HSX SMITH & NEPHEW 07EM13633

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability