BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1820021 · Received August 24, 2010

    Report

    Report Number
    1644408-2010-00458
    Event Type
    Other
    Date Received
    August 24, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT HAD INFECTION IN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSERT, ULTRA CONGRUENT JWH ENCORE MEDICAL, L.P. 987181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention