BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYLOC GHV 20G

    MDR report key: 3833797 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19500
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 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
    PHYSICIAN

    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. A 12-MONTH COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REVIEW OF THE DEVICE HISTORY RECORDS FOUND ONE UNRELATED NON-CONFORMANCE ON THIS BATCH; MICRO AND STERILITY TESTS PASSED. RETAINED CEMENT SAMPLES WERE TESTED FOR DOUGH TIME, SETTING TIME, AND HANDLING CHARACTERISTICS; ALL RESULTS WERE WITHIN FINAL PRODUCT SPECIFICATIONS. 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 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, WHICH SERVED TO CEMENT TIBIA, FEMUR AND PATELLA. THIS DOSE TOOK 17 MINUTES TO FULLY SET. A TIMER WAS PRESENT IN THE ROOM. THE TEMPERATURE OF THE ROOM WAS 19 DEGREES AS USUAL, IDENTICAL TO PREVIOUS REVISION SURGERIES BUT WITH AN INCREASED THE POLYMERIZATION TIME. THE SAMPLE KEPT BY THE SURGEON ON THE TABLE WAS POLYMERISED BUT IN SITU, UNDER THE IMPLANT THROUGH A SCALPEL BLADE, THE CEMENT WAS SOFT. THE SAME ISSUE OCCURRED DURING 2 DIFFERENT SURGERIES ON THAT DAY ((B)(6) 2014). (THE FIRST SURGERY RECORDED IN COM-052943). INFORMATION RECEIVED THAT THIS EVENT DID NOT OCCUR DURING A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311396 ACRYLOC GHV 20G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW REG. # 9610921 7489968

    Patients

    Seq Age Sex Outcome Treatment
    1