BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT TRAY SLEEVE POR M/L 29MM

    MDR report key: 7832643 · Received August 30, 2018

    Report

    Report Number
    1818910-2018-68149
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    November 6, 2017
    Report Date
    August 9, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295026402
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 192076. 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 WAS REVISED TO ADDRESS LOOSENING OF TIBIAL COMPONENT AT UNKNOWN INTERFACE. PROCEDURE: REVISION RIGHT KNEE REPLACEMENT. SURGEON: (B)(6). PREVIOUS REVISION RIGHT KNEE REPLACEMENT (PRIMARY & PRIOR REVISION DATES UNKNOWN). ON (B)(6) 2017 SURGEON REVISING KNEE DUE TO LOOSE COMPONENTS. ALL TIBIAL COMPLEMENTS REMOVED. FEMORAL STEM AND SLEEVE LEFT INSITU, TC3 FEMUR REPLACED WITH SROM HINGE COMPONENT. PATIENT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673722 MBT TRAY SLEEVE POR M/L 29MM MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY NJL DEPUY ORTHOPAEDICS INC US 192076 10603295026402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention