BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY COCR LINER

    MDR report key: 10678589 · Received October 14, 2020

    Report

    Report Number
    3010536692-2020-00658
    Event Type
    Injury
    Date Received
    October 14, 2020
    Report Date
    October 14, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS. IMPLANT WAS REMOVED. ADDITIONAL INFORMATION RECEIVED ON 09/23/2020 FROM (B)(6): ADDING PRODUCT INFORMATION AND UPDATING IMPLANT DATE. ADDITIONAL INFORMATION RECEIVED ON 09/25/2020 FROM (B)(6): CONFIRMATION OF THE PRODUCT NUMBER OF THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145013 DYNASTY COCR LINER HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. DLCOGC36 08636496010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention