BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEGA TOTAL KNEE

    MDR report key: 7979738 · Received October 17, 2018

    Report

    Report Number
    MW5080679
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    May 6, 2017
    Report Date
    May 11, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC / B. BRAUN
    Product Code
    JWH
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON "(B)(6) 2016" TIBIAL LOOSENED RIGHT KNEE. REVISED AS ONLY PART OF KNEE THAT FAILED AT THAT TIME, LATER LEARNED FEMUR WOULD FAIL. LATER (2 YEARS) - CURRENTLY KNOWN TOP PART OF KNEE FEMUR IS LOOSE. LEFT VEGA KNEE GLOBAL FAILURE, FEMUR AND TIBIA REVISED TO COLUMBUS LONG STEM. ASEPTIC LOOSENING OF ENTIRE CONSTRUCT. PREVIOUS VEGA DONE TO REVISE FAILED, UNICOMPARTMENT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814192 VEGA TOTAL KNEE PROSTHESIS KNEE, FEMOROTIBIAL CONSTRAINED CEMENTED, METAL / POLYMER JWH AESCULAP IMPLANT SYSTEMS, LLC / B. BRAUN VEGA
    814193 VEGA TOTAL KNEE REPLACEMENT PROSTHESIS KNEE, FEMOROTIBIAL CONSTRAINED CEMENTED, METAL / POLYMER JWH AESCULAP IMPLANT SYSTEMS, LLC / B. BRAUN VEGA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention