BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ3

    MDR report key: 1013865 · Received March 14, 2008

    Report

    Report Number
    1818910-2008-00628
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOT PROVIDED SINCE ITS RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIB TRAY SZ3 87NJL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 1881477

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention