BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELF CENT HIP 48X28 BRN

    MDR report key: 6876468 · Received September 19, 2017

    Report

    Report Number
    1818910-2017-24930
    Event Type
    Death
    Date Received
    September 19, 2017
    Date of Event
    August 20, 2017
    Report Date
    August 20, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWY
    UDI-DI
    10603295003380
    PMA / PMN Number
    K812672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTING THE REVISION PRODUCTS, THE PATIENT WAS CLOSED UP AND BEGAN EXPERIENCING PROBLEMS. THE PATIENT DIED IN ROOM. THE SURGEON LATER STATED THAT IT WAS PROBABLY DUE TO FAT EMBOLISM. COMPETITOR CEMENT WAS REPORTED TO BE USED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656111 SELF CENT HIP 48X28 BRN HIP OTHER IMPLANT KWY DEPUY ORTHOPAEDICS, INC.1818910 C47996 10603295003380

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death