BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE JUNIOR

    MDR report key: 1544245 · Received November 20, 2009

    Report

    Report Number
    1836248-2009-00003
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    November 1, 2009
    Report Date
    November 10, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    JWH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    "PATIENT WAS STANDING IN FRONT OF TV. STEPPED FORWARD. KNEE RELEASED, AND SHE FELL BACKWARD. SHE FELT A POP IN HER LEG." "BROKEN LEG AT MID THIGH. HOSPITALIZED AND PLACED IN FULL BODY CAST. RELEASED AFTER 2 DAYS. SHE IS BACK IN THE HOSPITAL WITH A URINARY INFECTION, AND OTHER HEALTH ISSUES. SHE WILL BE IN THE CAST FOR 6-8 WEEKS. VISIT ORTHOPEDIC SURGEON FOR POSSIBLE FUTURE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL KNEE JUNIOR JWH OSSUR AMERICAS TK1100

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R