BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE

    MDR report key: 7938661 · Received October 4, 2018

    Report

    Report Number
    MW5080382
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    December 28, 2015
    Report Date
    October 4, 2018
    Manufacturer
    MEDACTA USA, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED TO REPORT THAT SINCE HE HAS BEEN IMPLANTED WITH A TOTAL KNEE IMPLANT, HE HAS HAD PAIN, DISCOMFORT AND LOSS OF RANGE OF MOTION. THE IMPLANT IS AT TEN PERCENT DEFLEXION. REPORTER HAS BEEN TOLD BY THREE HEALTH PROFESSIONAL THAT HIS KNEE IMPLANT IS UNSTABLE AND EXPLORATORY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773890 TOTAL KNEE PROSTHESIS, KNEE JWH MEDACTA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability