BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE

    MDR report key: 3824903 · Received May 21, 2014

    Report

    Report Number
    0001811755-2014-01854
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE CONDITION WAS CONFIRMED UPON EVALUATION OF THE RETURNED CARTRIDGE COMPONENT. THE BREAKAGE OCCURRED AT THE PROXIMAL END OF THE CARTRIDGE, WHERE IT CONNECTS TO THE CEMENT INJECTION GUN. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE CARTRIDGE FROM THE ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE (ACM) BROKE DURING INJECTION, WHICH RESULTED IN AN HOUR AND A HALF DELAY IN THE PROCEDURE. IT COULD NOT BE CONFIRMED WHETHER OR NOT ADDITIONAL ANESTHESIA WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION WAS REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE CARTRIDGE FROM THE ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE (ACM) BROKE DURING INJECTION, WHICH RESULTED IN AN HOUR AND A HALF DELAY IN THE PROCEDURE. IT COULD NOT BE CONFIRMED WHETHER OR NOT ADDITIONAL ANESTHESIA WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301457 ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13324012 OR 13350012

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other