BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 1930247 · Received November 24, 2010

    Report

    Report Number
    1818910-2010-08217
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K023012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 DID NOT SET RIGHT RESULTING IN FAILURE OF THE CEMENT AND THE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET HV BONE CEMENT 40G 87 LOD LOD DEPUY CMW NA 3113239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA