BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 5934577 · Received September 7, 2016

    Report

    Report Number
    3010536692-2016-01136
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    February 18, 2014
    Report Date
    September 7, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (LEFT). ADDITIONAL INFORMATION RECEIVED 04/08/2016. ALLEGEDLY, THE PATIENT WAS REVISED DUE TO THE FOLLOWING MOM COMPLICATIONS: PAIN; METALLOSIS ( LEFT). ADDITIONAL INFORMATION RECEIVED 08/08/2016. ALLEGEDLY, THE PATIENT WAS REVISED DUE TO THE FOLLOWING MOM COMPLICATIONS: METALLOSIS; PAIN THAT PROGRESSIVELY WORSENED; INCREASED STABILITY (LEFT). (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584156 CONSERVE(R) PLUS CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 016304478

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention