BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1880512 · Received October 13, 2010

    Report

    Report Number
    1644408-2010-00536
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY, PT PRESENTED WITH AN INFECTED KNEE. ON (B)(6) 2010, THE ORIGINAL INSERT WAS REMOVED, THE KNEE WAS WASHED OUT AND A NEW INSERT WAS REPLACED. THE INFECTION DID NOT CLEAR UP AND ALL OF THE ORIGINAL COMPONENTS WERE REMOVED ON (B)(6) 2010. AN INSERT WAS PLACED IN AS AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSERT JWH ENCORE MEDICAL, L.P. 53999825

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention