BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER BONE CEMENT INJECTOR

    MDR report key: 1864849 · Received September 28, 2010

    Report

    Report Number
    1822565-2010-00823
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KIH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE TYPE OF CEMENT USED, THE TEMPERATURE OF THE CEMENT COMPONENTS AT THE TIME OF USE, THE CEMENT MIXING METHOD AND THE TIME FROM THE ONSET OF MIXING THAT THE CEMENT WAS EJECTED FROM THE CARTRIDGE ARE UNK. A RUPTURE OF THIS TYPE CAN BE CAUSED BY SEVERAL FACTORS SOME OF WHICH ARE - INCORRECT LOAD APPLICATION FROM THE GUN, SPECIFICALLY IF A POWER-FLOW INJECTOR WAS USED, IT MAY NOT HAVE BEEN SET TO THE "FILL" POSITION AS RECOMMENDED IN THE PACKAGE INSERT, CEMENT POLYMERIZATION MAY HAVE ADVANCED TO THE STATE WHERE ITS VISCOSITY WAS TOO HIGH TO PERMIT EJECTION FROM THE CARTRIDGE. BASED ON THE INFO AVAILABLE, A DEFINITIVE CAUSE FOR THE CARTRIDGE ISSUES EXPERIENCED CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    MILLER INJECTION CARTRIDGE BROKE DURING INJECTION OF BONE CEMENT. TIP AND RING AT BOTTOM OF CARTRIDGE BOTH BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER BONE CEMENT INJECTOR HIP INSTRUMENT KIH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1