BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MILLER BONE CEMENT INJECTOR

    MDR report key: 3030490 · Received March 27, 2013

    Report

    Report Number
    1526350-2013-00152
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE THE PRODUCT WAS DISCARDED AT THE HOSPITAL. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES DURING MANUFACTURE THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE ZIMMER MILLER BONE CEMENT INJECTOR, THE BOTTOM (FLANGE) OF CARTRIDGE BROKE WHILE INJECTING THE BONE CEMENT. IT WAS FURTHER REPORTED THAT SURGEON INSERTED CEMENT IN A MEDULLARY CAVITY BY HAND. THERE WAS NO HARM OR SURGICAL DELAY REPORTED. THERE WAS NO INFORMATION RECEIVED AS TO WHETHER ANY BROKEN PIECES ENTERED THE PATIENT OR REQUIRED RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126818 ZIMMER MILLER BONE CEMENT INJECTOR ZIMMER MILLER BONE CEMENT INJECTOR KIH ZIMMER SURGICAL NA 62066667

    Patients

    Seq Age Sex Outcome Treatment
    1