BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS HA CUP

    MDR report key: 6301755 · Received February 3, 2017

    Report

    Report Number
    3010536692-2017-00201
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 26, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS SUFFERING FROM HIP PAIN. MR. (B)(6) DECIDED TO REVISE THE CONSERVE BFH AND CUP AND MODULAR NECK.THE PROFEMUR L STEM WAS LEFT IN SITU. A NEW AR8 SHORT NECK WAS IMPLANTED ALONG WITH A DE PUY PINNACLE CUP WITH POLY LINER. MR (B)(6) STATED THAT THE PAIN WAS CAUSED BY WEAR DUE TO SUBLUXATION AND EDGE LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84135 CONSERVE(R) PLUS HA CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 057419414

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention