BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1943659 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00671
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT COMPLAINED OF PATELLA-FEMORAL PAIN. THE DOCTOR REMOVED A SIGNIFICANT AMOUNT OF SCAR TISSUE AND RESHAPED THE PT'S PATELLA WITH AN OSTEOTOMY. A PATELLA BUTTON WAS THEN REPLACED AND A POLY TIBIAL COMPONENT EXCHANGE WAS ALSO PERFORMED. NORMAL WEAR OF POLY COMPONENTS WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE POLY PATELLA JWH ENCORE MEDICAL, L.P. 509441

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention