BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE

    MDR report key: 1617363 · Received February 22, 2010

    Report

    Report Number
    3003764610-2010-00001
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    September 24, 2009
    Report Date
    February 19, 2010
    Manufacturer
    OSSUR H/F
    Product Code
    ISW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THIS UNIT (B) (4), LOAD CELL WAS EXCHANGED. A MEETING HAS BEEN SCHEDULED TO REVIEW THE (B) (4) FOR THE LOAD CELL FAILURE, INSTRUCTIONS FOR USE, WARNING AND DECIDE WHAT ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    PT IS BI-LATERAL ABOVE KNEE AMPUTEE. PT HAS FALLEN BECAUSE THE RIGHT KNEE LOCKS UP IN MID SWING. WHEN THE KNEE LOCKS IN THE FLEXED POSITION, IT DOES NOT PROVIDE THE NECESSARY SUPPORT AND THE PT GOES DOWN. THE LAST TIME HE FELL, HE INJURED HIS SHOULDER. WE LEARNED OF THIS INJURY ON (B) (6) 2010. THE PT'S SHOULDER WAS REBUILT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEO KNEE ISW OSSUR H/F RKN120007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization