BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ3

    MDR report key: 3073188 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15781
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 29, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE INITIAL REPORTING STATED RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS SYNOVITIS WITH WEAR DEBRIS AND A TIBIAL COMPONENT THAT WAS LOOSE. THE PATELLAR COMPONENT APPEARED TO BE INTACT AND THEREFORE WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174891 MBT CEM KEEL TIB TRAY SZ3 TIBIAL NJL 9616671 DEPUY (IRELAND) 2502098

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention