BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD

    MDR report key: 6059500 · Received October 26, 2016

    Report

    Report Number
    3010536692-2016-01326
    Event Type
    Injury
    Date Received
    October 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PER PAPER BY SOMERS ET AL., "HIGH SERUM ION LEVELS IN CONSERVE PLUS BIG FEMORAL HEAD CEMENTED TOTAL HIP ARTHROPLASTY.", HIP INT. 2016 SEP: ALLEGEDLY LEFT HIP OF YOUNG FEMALE (NO AGE STATED) REVISED AT 3 YEARS FOR HIGH SERUM COBALT LEVELS (28 MICROGRAM/LITER AT 3 YEARS). PATIENT ORIGINALLY WAS IMPLANTED WITH BILATERAL THA AND AT 3 YEARS HAD CUP ANGLES OF 43 AND 42 DEG AND NORMAL MRI FINDINGS. PATIENT EXHIBITED LEFT-SIDED MILD PSOA TENDONITIS. FEMORAL STEM AND FEMORAL HEAD WERE REVISED, THE CUP WAS RETAINED AND CONVERTED TO A DUAL MOBILITY CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709359 CONSERVE(R) TOTAL HEAD HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention