BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT VACUUM CEMENT MIXING SYSTEM

    MDR report key: 1931968 · Received November 30, 2010

    Report

    Report Number
    1526350-2010-00174
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER "MIXING SYSTEM USED TO CEMENT KNEE COMPONENTS. THE CYLINDER'S FLANGE BROKE INTO SEVERAL PIECES WHILE IN CEMENT GUN DURING COMPRESSION TO SQUEEZE OUT CEMENT FROM CYLINDER. CEMENT WAS NOT HARD IN CYLINDER. CEMENT WAS NOT STIFF EITHER. RISK OF PIECES ENTERING PATIENTS OPEN WOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT VACUUM CEMENT MIXING SYSTEM COMPACT VACUUM CEMENT MIXING SYSTEM JDZ ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA 61588164

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR