BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER POWER-MIX VACUUM CEMENT MIXING SYSTEM

    MDR report key: 3973052 · Received April 29, 2014

    Report

    Report Number
    1526350-2014-00337
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER INFORMATION WAS PROVIDED, SO A RELEASE TO INVENTORY DATE COULD NOT BE DETERMINED. THERE WAS NO REVIEW OF THE QUALITY RECORDS BECAUSE A LOT NUMBER TO IDENTIFY THE PRODUCT WAS NOT GIVEN. THE COMPLAINT ABOUT THE BROKEN FLANGE WAS CONFIRMED. IT APPEARED AS THOUGH THE BONE CEMENT HARDENED DURING THE PROCEDURE. ONCE THE CEMENT HARDENED, THEN THE CEMENT WOULD NOT FLOW THROUGH THE SHAFT. IF CONTINUED FORCE ON THE CARTRIDGE BY THE CEMENT GUN THAT WAS USED, THEN THE FLANGE WOULD BREAK. BECAUSE NO TIMES WERE GIVEN ABOUT HOW LONG THE CEMENT WAS IN THE CARTRIDGE AND NO LOT NUMBERS ON THE CARTRIDGE OR BONE CEMENT WERE PROVIDED, A DIRECT CAUSE CANNOT BE DETERMINED; HOWEVER, THE CAUSE IS MOST LIKELY DUE TO HUMAN ERROR IN THAT THE CEMENT WAS ALREADY HARDENED AND BROKE THE FLANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER POWER-MIX VACUUM CEMENT MISSING SYSTEM FLANGE OF THE CARTRIDGE HAD BEEN FRACTURED DURING INJECTING THE BONE CEMENT INTO FEMORAL CANAL. THE SURGERY WAS FINISHED WITH ANOTHER ZIMMER POWER-MIX AND BONE CEMENT. THE BROKEN PIECES HAD NOT FALLEN INTO THE PATIENT, AND ADDITIONAL PROCEDURE TIME WAS ATTRIBUTED TO PREPARATION FOR ANOTHER BONE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255545 ZIMMER POWER-MIX VACUUM CEMENT MIXING SYSTEM ZIMMER POWER-MIX VACUUM CEMENT MIXING JDZ ZIMMER SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1