BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE PLUS CUP

    MDR report key: 1012622 · Received March 10, 2008

    Report

    Report Number
    1043534-2008-00033
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 21, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K031963
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADD'L INFO HAS BEEN REQUESTED FROM THE USER FACILITY AND THE SURGEON. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED. THIS IS THE SAME EVENT AS 1043534-2008-00035.

    Description of Event or Problem · 1

    DX: R HIP OSTEOARTHRITIS/OSTEONECROSIS. PMHX: HYPERLIPIDEMIA, HX/O COLON AND RECTAL CANCER S/P CHEMO AND RADIATION THERAPY. ALLEGEDLY PT DID WELL INITIALLY POST-OP AND THEN BEGAN EXPERIENCING THIGH AND GROIN PAIN IN 2006. PAIN WAS MINIMAL UNTIL 2008. PT ROSE FROM BED ONE MORNING AND BEGAN EXPERIENCING SEVERE GROIN PAIN. NO RELIEF FROM MEDS. PT CAME TO THE OFFICE AND HIS CONSERVE PLUS CUP HAD VERTICALLY SHIFTED. HE WAS REVISED TO A TRABECULAR METAL CUP W/POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE PLUS CUP KWA WRIGHT MEDICAL TECHNOLOGY, INC. 095257644

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R