BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2

    MDR report key: 7051806 · Received November 21, 2017

    Report

    Report Number
    1818910-2017-50135
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 24, 2017
    Report Date
    October 24, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    UDI-DI
    10603295025764
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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

    THE PATIENT HAS A DEPUY SYNTHES LTK. THE PATIENT WAS SCHEDULED TO HAVE THEIR POLYETHYLENE TIBIAL INSERT EXCHANGED TO A THICKER SIZE TO ADDRESS SOME KNEE JOINT LAXITY. THE SURGEON PLANNED TO EXPLORE THE FEMORAL, TIBIAL AND PATELLA COMPONENT INTERFACES TO DETERMINE IF THEY WERE LOOSE. UPON EXPLORATION OF THE TIBIAL TRAY, IT WAS DETERMINED TO BE LOOSE. THE SURGEON ELECTED TO EXTRACT THE WELL FIXED FEMORAL COMPONENT AS WELL AND TO RE-IMPLANT REVISION STYLE COMPONENTS. THE PATELLA COMPONENT WAS ALSO DEEMED TO BE WELL FIXED TO THE HOST BONE AND THEREFORE IT WAS RETAINED. IT WAS ALSO REPORTED THAT THE LOOSENING INTERFACE WAS CEMENT/IMPLANT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828869 MBT CEM KEEL TIB TRAY SZ2 KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS, INC. 1818910 3260534 10603295025764

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention