BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESCULAP VEGA KNEE SYSTEM

    MDR report key: 19105013 · Received April 12, 2024

    Report

    Report Number
    MW5153839
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 10, 2024
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POLYETHYLENE FRACTURE POST ON A LEFT TOTAL KNEE POSTERIOR STABILIZED IMPLANT. POSITIVE POSTERIOR DRAWER WITH EVIDENCE OF POST FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775712 AESCULAP VEGA KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH AESCULAP IMPLANT SYSTEMS, LLC 51655957

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention