BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER INJECTION CARTRIDGE KIT

    MDR report key: 1864855 · Received September 28, 2010

    Report

    Report Number
    1822565-2010-00828
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 25, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS REPORTED AS DISCARDED BY THE HOSPITAL. THEREFORE NO ASSESSMENT TO THE CONDITION OF THE CARTRIDGE MATERIAL PROPERTY CAN BE MADE TO CONFIRM OR REFUTE THE SURGEON'S CLAIM. 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. ONE OR A COMBINATION OF THE FOLLOWING FACTORS MAY HAVE CONTRIBUTED TO THE EXPERIENCE OBSERVED: THE DESCRIPTION, "COLD JOINT" IS NOT CLEARLY UNDERSTOOD FROM THE EVENT DESCRIPTION, HOWEVER IF A COLD CONDITION EXISTED IN THE CEMENT IT IS POSSIBLE FOR THIS TO LEAD TO AN ADVANCE IN CEMENT POLYMERIZATION AND AN INCREASE IN THE CEMENT VISCOSITY INCREASING THE PUMPING PRESSURE LEADING TO A FRACTURE OF THE CARTRIDGE FLANGE. AN ISSUE WITH THE POWERFLOW CEMENT GUN WITH THE INTERFACING COMPONENT OR THE WITH THE "FILL" SETTING. THE GUN HAS NOT BEEN RETURNED SO THIS CANNOT BE ASSESSED. AN ISSUE WITH THE GUN IS CONSIDERED UNLIKELY DUE TO THIS DEVICE BEING A MULTIPLE USE ITEM. BASED ON THE INFO AVAILABLE, A DEFINITIVE CAUSE FOR THE EXPERIENCE OBSERVED CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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

    IT IS REPORTED THAT THE CARTRIDGE FLANGE FRACTURED WHILE INJECTING THE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER INJECTION CARTRIDGE KIT HIP INSTRUMENT KIH ZIMMER, INC. 61247676

    Patients

    Seq Age Sex Outcome Treatment
    1