BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS(R) HEAD W/BFH

    MDR report key: 3851057 · Received June 5, 2014

    Report

    Report Number
    3010536692-2014-00889
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY, THE SURGEON FOUND THE RISE FOR METAL ION VALUE IN THE BLOOD AT ROUTINE MEDICAL CHECKUP. THE SURGEON PERFORMED REVISION SURGERY. MEDIUM ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330065 CONSERVE(R) TOTAL A-CLASS(R) HEAD W/BFH HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 087469500

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention