BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2.5

    MDR report key: 8013697 · Received October 29, 2018

    Report

    Report Number
    1818910-2018-73698
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 9, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. US 1818910
    Product Code
    NJL
    UDI-DI
    10603295025771
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : PRODUCT CODE 129433125, LOT NUMBER 8052762. DEVICE HISTORY REVIEW : (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853783 MBT CEM KEEL TIB TRAY SZ2.5 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS, INC. US 1818910 8052762 10603295025771

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention