BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY(R) COCR LINER

    MDR report key: 7861751 · Received September 10, 2018

    Report

    Report Number
    3010536692-2018-01170
    Event Type
    Injury
    Date Received
    September 10, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO THE FOLLOWING MOM COMPLICATIONS: ELEVATED COBALT AND CHROMIUM ION LEVELS; INCREASED DISCOMFORT; PAIN (RIGHT) PATIENT HAD A STELKAST® PROVIDENT STEM SC2647-8.75 21586-041509.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702768 DYNASTY(R) COCR LINER HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. DLCO-GE40 0301081699

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention