BEUDAMED
    FDA Adverse Event Death Summary report: N

    DLC FLEX DRILL SHAFT

    MDR report key: 1053072 · Received May 22, 2008

    Report

    Report Number
    1818910-2008-01905
    Event Type
    Death
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    IN 2008, TOTAL HIP ARTHROPLASTY WAS DONE FOR OA. DURING OPERATION WHEN THE DOCTOR WAS CLOSING THE OPERATIVE FIELD AFTER INSERTING THE IMPLANTS, THE BLOOD PRESSURE DROPPED. ANESTHETIST DID ADDITIONAL PROCEDURE. AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO RECEIVE FURTHER SURGICAL PROCEDURE. THE PATIENT DIED OF MASSIVE BLOOD LOSS ON TWO DAYS LATER. *THERE IS A POSSIBILITY THAT BLOOD VESSEL WOULD HAVE BEEN DAMAGED DURING INSERTING THE IMPLANTS OR THE PROCEDURE BEFORE INSERTION. AMENDMENT 05/08/2008 - FROM THE * IN ABOVE ORIGINAL. THERE WAS A POSSIBILITY THAT THE DOCTOR DAMAGED THE TISSUES WITHIN THE ABDOMEN BY PENETRATING ACETABULUM BY DRILL BIT DURING THE PROCEDURE FOR ACETABULUM. BLEEDING POINT COULD NOT BE CONFIRMED BY OPENING THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLC FLEX DRILL SHAFT 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA AG0807

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death