BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2

    MDR report key: 1032517 · Received April 21, 2008

    Report

    Report Number
    1818910-2008-01225
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, INFORMATION PROVIDED IN THE INITIAL REPORT SUGGESTS THAT THE PLACEMENT OF THE TIBIAL TRAY IN THE INITIAL SURGERY DID NOT ACHIEVE THE DESIRED RESULTS. THE INITIAL REPORT STATES, THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. 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 VALGUS PLACEMENT OF THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIB TRAY SZ2 87NJL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2191814

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention