BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAULIK CYLINDER JR.

    MDR report key: 522117 · Received July 4, 2004

    Report

    Report Number
    3003764610-2004-00002
    Event Type
    Injury
    Date Received
    July 4, 2004
    Date of Event
    March 8, 2004
    Report Date
    June 4, 2004
    Manufacturer
    OSSUR HF
    Product Code
    ISW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT FELL WHEN THE KNEE UNIT LOCKED UP INJURING THEIR AMPUTATED LIMB. PT HAD A METAL ROD IN THEIR FEMUR, WHICH WAS BENT WHEN PT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAULIK CYLINDER JR. EXTERNAL PROSTHETIC KNEE ISW OSSUR HF SNJ01800U *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention HYDRAULIK CYLINDER JR. (2003 TO 2004).