BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMW 40G US EO

    MDR report key: 1275070 · Received December 22, 2008

    Report

    Report Number
    1818910-2008-06101
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K081163
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLIANT 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

    SURGEON MIXED THE SMARTSET (LOT 2623504) AS INDICATED, AND AS HE NORMALLY DOES, THAT INCLUDED A VACUUM MIXED SYSTEM FROM STRYKER. SURGEON PRESSED A SMALL BALL OF CEMENT AFTER TWO (2) MINUTES AND EXPRESSED THAT THE CEMENT FELT DIFFERENT. HE CEMENTED THE TIBIAL COMPONENT. AT AROUND FIVE (5) MINUTES, THE CEMENT BECAME MORE VISCOUS THAN HE NORMALLY EXPECTED, AND LAYERED THE FEMORAL COMPONENT AND SQUEEZED CEMENT ONTO THE FEMUR. THIS IS WHERE HE NOTICED THAT THE CEMENT WAS NOT HANDLING THE SAME AS THE PREVIOUS PRODUCT. AS HE PRESSED AND MALLETED THE FEMORAL COMPONENT, HE NOTICED THAT THE CEMENT HAD ALREADY BECOME THICKER AND WAS NOT EXTRUDING EASILY. HE DECIDED TO REMOVE THE CEMENT OFF THE FEMORAL COMPONENT AND THE DISTAL FEMUR AND REMIX ANOTHER BATCH OF THE SAME CEMENT. THE SECOND BATCH SET IN THE SAME AMOUNT OF TIME AS THE FIRST (9-1/2 MINUTES). THIS CAUSED A SURGICAL DELAY OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GMW 40G US EO 87LOD LOD DEPUY CMW NA 2623504

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR