BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 3802485 · Received May 9, 2014

    Report

    Report Number
    3010536692-2014-00778
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (RIGHT). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281805 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 015167727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention