BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION KNEE

    MDR report key: 3080823 · Received April 26, 2013

    Report

    Report Number
    1644408-2013-00240
    Date Received
    April 26, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K905613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT FELL AND POSSIBLY FRACTURED HER PATELLA. THE ONLY IMPLANTS THAT WERE REMOVED WERE THE PATELLA AND INSERT; A NEW INSERT WAS REPLACED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182390 FOUNDATION KNEE PRIMARY INSERT, SIZE 4, 9MM JWH ENCORE MEDICAL, L.P. 614661

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention (B)(4), LOT 951371