BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CEMENT MIXING BOWL AN

    MDR report key: 1014049 · Received March 15, 2008

    Report

    Report Number
    2648666-2008-00029
    Event Type
    Malfunction
    Date Received
    March 15, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    STRYKER PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RECEIVED FOR EVALUATION, BUT THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BASE OF THE SYRINGE CRACKED THE FIRST TIME THE SURGEON PULLED THE TRIGGER OF THE CEMENT GUN AFTER MIXING. ANOTHER ACM WAS USED, HOWEVER, THE SURGEON COULD NOT REMOVE THE SIMPLEX CEMENT THAT HAD BEEN PARTIALLY INJECTED INTO THE INTRAMEDULLARY. AS A RESULT THE SURGEON CHANGED THE SIZE OF THE STEM, "BECAUSE THE DISTAL PART OF THE STEM AND COMPLETED THE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED CEMENT MIXING BOWL AN MIXER, CEMENT, FOR CLINCIAL USE JDZ STRYKER PUERTO RICO 07283012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK