BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY/CMW 2G

    MDR report key: 1082518 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02984
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    DEPUY GMW
    Product Code
    MBB
    PMA / PMN Number
    K061144
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CEMENT SET UP AT 3 MINUTES WHICH WAS WAY TOO SOON CAUSING A 1 HOUR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY/CMW 2G 87MBB MBB DEPUY GMW NA CK7K31000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR