BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) RESURFACING HEAD

    MDR report key: 7593860 · Received June 12, 2018

    Report

    Report Number
    3010536692-2018-00793
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    June 12, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED ITEM NUMBER.

    Description of Event or Problem · 1

    ALLEGEDLY, PER ARTICLE BY DOWDING AND BEAULE, ET AL. J ARTHROP. 2018: A PATIENT SUFFERED FAILURE BECAUSE OF ADVERSE TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433299 CONSERVE(R) RESURFACING HEAD HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 38XX-XXXX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention