BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 5093033 · Received September 21, 2015

    Report

    Report Number
    3010536692-2015-01759
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    May 27, 2015
    Report Date
    August 23, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2015-01758.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: BONE CYSTS; PSEUDO-TUMORS; METALLOSIS AND OSTEOLYSIS; HIGH LEVEL OF METAL IONS; DETACHMENT, DISCONNECTION, AND/OR LOOSENING OF THE ACETABULAR CUP; AND LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623974 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 099931106

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention