BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 50OD X 28ID

    MDR report key: 879586 · Received July 10, 2007

    Report

    Report Number
    1818910-2007-02032
    Event Type
    Injury
    Date Received
    July 10, 2007
    Date of Event
    May 21, 2007
    Report Date
    June 11, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE OBSERVATION. DEVICE AND RECORDS EVALUATION, HOWEVER, DID NOT IDENTIFY OR VERIFY ANY PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ADDITIONALLY, THE INVESTIGATION HAS DETERMINED THAT THIS PRODUCT CODE HAS BEEN INACTIVE/OBSOLETE SINCE SEPTEMBER OF 2003.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE THE INSERT WAS WORN AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 50OD X 28ID 87KWY KWY DEPUY ORTHOPAEDICS, INC. NA 865500025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention