BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE

    MDR report key: 8119818 · Received November 29, 2018

    Report

    Report Number
    MW5081751
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    June 26, 2018
    Report Date
    November 28, 2018
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A DEPUY ATTUNE KNEE REPLACEMENT THAT IS NOW LOOSE. I HAVE HAD 3 ORTHOPEDIC DRS EXAMINE MY KNEE AND ALL OF THEM STATE THAT IT IS LOOSE. TIBIAL LOOSENING IS WHAT THE LAST SURGEON HAS SAID IS WRONG WITH MY KNEE AND THAT IT HAS TO BE REVISED. I AM EXPERIENCING DAILY PAIN BECAUSE OF IT BEING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958154 ATTUNE PROSTHESIS KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/ JWH DEPUY SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other