BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION PATELLAR COMPONENTS

    MDR report key: 1220547 · Received November 3, 2008

    Report

    Report Number
    1644408-2008-00385
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    June 22, 2007
    Report Date
    April 25, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - LEFT KNEE PATELLA, TIBIAL INSERT, TIBIA BASEPLATE, AND FEMUR. ENCORE FIRST BECAME AWARE OF THE REVISION SURGERY IN 2008. DUE TO AN INTERNAL MISCOMMUNICATION, THE CORRECT DEPT WAS NOT NOTIFIED OF THE REVISION SURGERY UNTIL SIX MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION PATELLAR COMPONENTS PATELLA, ALL-POLY 10MM X 38MM HTG ENCORE MEDICAL, L.P. 813351

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 203-01-006| 323-01-104| 360-15-504