BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE 3 W/LOCK

    MDR report key: 6764679 · Received August 3, 2017

    Report

    Report Number
    3003764610-2017-00003
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    June 26, 2017
    Report Date
    November 17, 2017
    Manufacturer
    OSSUR H/F
    Product Code
    ISW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOWER LIMB AMPUTEE PATIENT WEARING A RHEO KNEE 3 PROSTHETIC HAS FALLEN WHILE WALKING. ACCORDING TO HIS STATEMENT, HE WENT TO THE CAR WHEN HE WAS APPROACHED BY A FRIEND FROM THE REAR LEFT. HE TURNED AROUND WHILE WALKING AND THEN WANTED TO CONTINUE THE STEP WITH HIS PROSTHESIS ON THE RIGHT. HOWEVER, HE JUST FELL INTO A 'HOLE' AND FELL ON HIS FEMUR CONDYLES (KNEE EX AMPUTATED). HE DESCRIBES THE SITUATION AS THAT THE KNEE SIMPLY WAS NOT THERE AS USUAL. PATIENT SUSTAINED A FRACTURED FEMUR.

    Description of Event or Problem · 1

    LOWER LIMB AMPUTEE PATIENT WEARING A RHEO KNEE 3 PROSTHETIC HAS FALLEN WHILE WALKING. ACCORDING TO HIS STATEMENT, HE WENT TO THE CAR WHEN HE WAS APPROACHED BY A FRIEND FROM THE REAR LEFT. HE TURNED AROUND WHILE WALKING AND THEN WANTED TO CONTINUE THE STEP WITH HIS PROSTHESIS ON THE RIGHT. HOWEVER, HE JUST FELL INTO A 'HOLE' AND FELL ON HIS FEMUR CONDYLES (KNEE EX AMPUTATED). HE DESCRIBES THE SITUATION AS THAT THE KNEE SIMPLY WAS NOT THERE AS USUAL. PATIENT SUSTAINED A FRACTURED FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546218 RHEO KNEE 3 W/LOCK PROSTHETIC KNEE LOWER LIMB ISW OSSUR H/F RKN13110

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention