BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CMS W/BREAKAWAY

    MDR report key: 1589203 · Received January 13, 2010

    Report

    Report Number
    2648666-2010-00025
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 9, 2009
    Report Date
    December 17, 2009
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    K912190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. IT IS UNKNOWN AT THIS TIME HOW THE BLACK SPECS WERE INTRODUCED INTO THE CEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE REPLACEMENT CASE, THE CEMENT WAS BEING MIXED IN THE MIXER. BLACK SPECS WERE NOTICED IN THE CEMENT PRIOR TO USE. THE HEALTH CARE PROVIDER MADE THE DECISION TO USE THE CEMENT WITH THE SPECS. NO ADDITIONAL TREATMENT WAS PRESCRIBED TO THE PATIENT AS A RESULT OF THIS EVENT AND THE CEMENT PERFORMED AS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK