BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE 2000

    MDR report key: 7049167 · Received November 21, 2017

    Report

    Report Number
    1836248-2017-00002
    Event Type
    Injury
    Date Received
    November 21, 2017
    Report Date
    November 29, 2017
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT WEARING PROSTHETIC HYDRAULIC KNEE BENT THE KNEE TO GET INTO THE CAR. TO KEEP IT BENT, HE PLACED HIS FINGER ON THE PROSTHETIC KNEE. THE KNEE THEN STRETCHED OUT UNINTENTIONALLY, AND BECAUSE OF THE SCREW (WHERE HIS FINGER PUSHED) HIS FINGERTIP WAS PULLED BETWEEN THE AXES AND TORN OFF. THE V!GO TECHNICIAN HAD SHOWN THE PATIENT HOW TO GET IN THE CAR THE FIRST TIME & POINTED OUT HOW TO AVOID CONTACT WITH HANDS OR FINGERS IN MOVING PARTS. PATIENT HAD THE FINGERTIP SEWN BACK ON.

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT WEARING PROSTHETIC HYDRAULIC KNEE BENT THE KNEE TO GET INTO THE CAR. TO KEEP IT BENT, HE PLACED HIS FINGER ON THE PROSTHETIC KNEE. THE KNEE THEN STRETCHED OUT UNINTENTIONALLY, AND BECAUSE OF THE SCREW (WHERE HIS FINGER PUSHED) HIS FINGERTIP WAS PULLED BETWEEN THE AXES AND TORN OFF. THE V!GO TECHNICIAN HAD SHOWN THE PATIENT HOW TO GET IN THE CAR THE FIRST TIME & POINTED OUT HOW TO AVOID CONTACT WITH HANDS OR FINGERS IN MOVING PARTS. PATIENT HAD THE FINGERTIP SEWN BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830381 TOTAL KNEE 2000 PROSTHETIC KNEE JOINT COMPONENT ISY OSSUR AMERICAS, INC. 2000-OS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention