BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE HIGH ACTIVITY

    MDR report key: 6976396 · Received October 25, 2017

    Report

    Report Number
    1836248-2017-00001
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT FELL WHILE WEARING A TOTAL KNEE HIGH ACTIVITY PRODUCT AND EXPERIENCED A HEMATOMA RESULTING IN A DOCTOR VISIT. PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT FELL WHILE WEARING A TOTAL KNEE HIGH ACTIVITY PRODUCT AND EXPERIENCED A HEMATOMA RESULTING IN A DOCTOR VISIT. PATIENT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757069 TOTAL KNEE HIGH ACTIVITY PROSTHETIC KNEE ISY OSSUR AMERICAS, INC. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention