BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CMS W/BREAKAWAY

    MDR report key: 3131848 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01227
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AFTER PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVOLUTION CEMENT MIXER W/BREAKAWAY NOZZLE WAS BEING USED IN A TOTAL KNEE ARTHROPLASTY WHEN DURING THE INJECTION, THE CEMENT LEAKED OUT OF THE NOZZLE AND THE SIDE OF THE TOP LID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237142 REVOLUTION CMS W/BREAKAWAY MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13087012

    Patients

    Seq Age Sex Outcome Treatment
    1