BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2.5

    MDR report key: 7530379 · Received May 21, 2018

    Report

    Report Number
    1818910-2018-60113
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    April 23, 2018
    Report Date
    April 23, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    UDI-DI
    10603295025771
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-(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-(B)(4), LOT NUMBER 2722606 DEVICE HISTORY REVIEW ==> PRODUCT CODE-(B)(4), WORK ORDER -(B)(4) WAS MANUFACTURED ON DATE (B)(6)2008, 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING AT THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: 2008. DOR: (B)(6) 2018. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371954 MBT CEM KEEL TIB TRAY SZ2.5 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS, INC. 1818910 2722606 10603295025771

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention