BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYLOC GHV 20G

    MDR report key: 3833813 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19499
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    DEPUY CMW REG. # 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK023012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. A ROOT CAUSE CANNOT BE DETERMINED AS THE ORIGINAL PRODUCT HAS NOT BEEN RETURNED AND THE LOT NUMBER IS UNKNOWN SO THE RETAINED SAMPLES CANNOT BE TESTED. HOWEVER ONE OF THE FOLLOWING COULD OF POTENTIALLY AIDED THE UNCHARACTERISTIC BEHAVIOUR NOTED. CONDITIONING AND STORAGE OF THE SAMPLES OPERATING THEATRE TEMPERATURE THE MIXING AND USE OF BONE CEMENT CAN BE SIGNIFICANTLY AFFECTED BY EXPOSURE TO HIGH OR LOW TEMPERATURES UP TO 24 HOURS BEFORE USE. THIS CAN CAUSE WIDE FLUCTUATIONS IN WORKING AND SETTING TIME. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    DURING A TOTAL KNEE REVISION SURGERY, A DOSE OF CEMENT SMARTSET GHV WAS USED. THIS DOSE TOOK 17 MINUTES TO FULLY SET. THE TEMPERATURE OF THE ROOM WAS 19 DEGREES, THIS TEMPERATURE IS IDENTICAL TO PREVIOUS REVISION SURGERIES. THE SAMPLE KEPT BY THE SURGEON ON THE TABLE WAS POLYMERISED BUT IN SITU, THE CEMENT WAS SOFT. THE SAME ISSUE OCCURRED DURING 2 DIFFERENT SURGERIES ON THAT DAY ((B)(6) 2014). (THE SECOND SURGERY RECORDED IN COM-052790).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310622 ACRYLOC GHV 20G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW REG. # 9610921 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1