BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 7865074 · Received September 11, 2018

    Report

    Report Number
    1818910-2018-69000
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 15, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. CONCOMITANT MEDICAL PRODUCTS: SIGMA PS CEM FEM SZ3 R, 196050300; PFC SIGMARP STB TB IN 3 15.0, 962133.

    Additional Manufacturer Narrative · 1

    PC-(B)(4).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 WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014 - INSERT; DOI: (B)(6) 2009 - TIBIAL TRAY, FEMORAL COMPONENT AND 2 CEMENT; DOR: (B)(6) 2018 RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706592 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 2946615 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention