BEUDAMED
    FDA Adverse Event Death Summary report: N

    CEMVAC*SINGLE SYRINGE SET

    MDR report key: 2625727 · Received June 22, 2012

    Report

    Report Number
    1818910-2012-15326
    Event Type
    Death
    Date Received
    June 22, 2012
    Date of Event
    June 3, 2012
    Report Date
    August 13, 2012
    Manufacturer
    DEPUY CMW
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF THE COMPLAINTS DATABASES FOR THE LOT CODES OF THE PRODUCTS INVOLVED IN THE PROCEDURE ((B)(4)) IDENTIFIED NO PREVIOUS COMPLAINTS. IT WAS NOTED THAT THE CEMENT USED IN THE PROCEDURE WAS A ZIMMER PRODUCT AND NOT A DEPUY PRODUCT. THIS USE OF THE DEPUY DEVICES IS NOT RECOMMENDED. IT HAS BEEN REPORTED IN PREVIOUS MEDICAL CASES THAT IN RARE CIRCUMSTANCES THE USE OF CEMENT CAN CAUSE CARDIAC ARREST. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED ON LOTS (B)(4) WITH THE RESULT THAT NO ANOMALIES WERE FOUND. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PATIENT WHO WAS BEING OPERATED ON FOR RIGHT HIP HEMIARTHROPLASTY, SUDDENLY ARRESTED AFTER THE CEMENT WAS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMVAC*SINGLE SYRINGE SET INSTRUMENT LXH DEPUY CMW 11020132

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death