BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS SPIKED CUP

    MDR report key: 4822146 · Received June 5, 2015

    Report

    Report Number
    3010536692-2015-01262
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    September 18, 2012
    Report Date
    May 7, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2015-01261, -01263.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO MOM COMPLICATION: HIP PAIN; ELEVATED BLOOD COBALT LEVELS; PEACH-COLORED FLUID; EXTENSIVE FIBROSIS; EXTENSIVE GRANULATION TISSUE; SECTIONS OF BONE CONTAINING LYMPHOCYTES AND PLASMA CELLS AS WELL AS SOFT TISSUE CONTAINING PATCH CHRONIC INFLAMMATION LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364482 CONSERVE(R) PLUS SPIKED CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 079862975

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention