BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ4

    MDR report key: 1221963 · Received November 5, 2008

    Report

    Report Number
    1818910-2008-04787
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 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
    KY, 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 ERROR CONTRIBUTION TO THE REPORTED PROBLEM. IMPROPER DRILL OR PUNCH DEPTH MAY HAVE BEEN A CONTRIBUTING FACTOR. 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

    TIBIA FRACTURED DURING IMPLANTATION OF TIBIAL TRAY, EXTENDING THE SURGICAL PROCEDURE BY ONE (1) HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIB TRAY SZ4 87JNL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2728884

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention