BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE

    MDR report key: 11777646 · Received May 5, 2021

    Report

    Report Number
    3003764610-2021-00002
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    June 2, 2021
    Manufacturer
    OSSUR HF.
    Product Code
    ISW
    UDI-DI
    05690967598433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT FELL AS HE STEPPED BACKWARDS FROM MULCH ONTO HIS DRIVEWAY. THE PATIENT SUFFERED A FRACTURE TO THE FEMUR WHICH REQUIRED SCREWS. PATIENT IS RECOVERING WELL.

    Description of Event or Problem · 1

    PATIENT FELL AS HE STEPPED BACKWARDS FROM MULCH ONTO HIS DRIVEWAY. THE PATIENT SUFFERED A FRACTURE TO THE FEMUR WHICH REQUIRED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673459 RHEO KNEE PROSTHETIC KNEE ISW OSSUR HF. RKN130005 05690967598433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other