BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT CHROME

    MDR report key: 2250264 · Received September 15, 2011

    Report

    Report Number
    1020279-2011-00364
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    June 10, 2011
    Report Date
    September 15, 2011
    Manufacturer
    SMITH AND NEPHEW, INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO MANIPULATE AND INSERT THE PRODUCT, THE SURGERY TIME WAS DELAYED GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT CHROME FEMORAL COMPONENT JDI SMITH AND NEPHEW, INC 09KM10518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other