BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT REVISION CEM TIB TRAY SZ 5

    MDR report key: 2930197 · Received January 25, 2013

    Report

    Report Number
    1818910-2013-11544
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE AND PAIN. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35197 MBT REVISION CEM TIB TRAY SZ 5 TIBIAL KNEE PROSTHESIS NJL DEPUY ORTHOPAEDICS, INC. B5LCP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention