BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE 2000

    MDR report key: 9961406 · Received April 15, 2020

    Report

    Report Number
    0001836248-2020-00001
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    April 2, 2020
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    PATIENT FELL AND BROKE HER LEG.

    Description of Event or Problem · 1

    PATIENT FELL AND BROKE HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425733 TOTAL KNEE 2000 PROSTHETIC KNEE ISY OSSUR AMERICAS 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other