BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2120949 · Received May 30, 2011

    Report

    Report Number
    2120949
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 30, 2011
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS HAD BILATERAL TOTAL HIP REPLACEMENTS WITH METAL-ON-METAL PROSTHESES. BOTH INITIAL OPERATIONS OCCURRED IN 2008. FOLLOWING THE SECOND OPERATION, PATIENT DID HAVE EVIDENCE OF MOVEMENT OF THE ACETABULAR COMPONENT, WHICH WAS REPLACED WITH A SPIKED COMPONENT AND THERE WAS NO EVIDENCE OF PROBLEM IN HIS POSTOPERATIVE PERIOD. MOST RECENTLY, PATIENT PRESENTED WITH GAS IN THE JOINT AND ACUTE PAIN SEVERAL WEEKS AGO. AFTER EVALUATION, DOCTOR DETERMINED THAT THE GAS IS MOST LIKELY HYDROGEN AND BELIEVES THAT THIS IS MOST LIKELY ORIGINATING FROM CORROSION OF THE MODULAR NECK. PATIENT WAS EVALUATED FOR METAL-METAL SENSITIVITY AND FOUND NO EVIDENCE OF THIS WITH A CT SCAN. HIS METAL LEVELS ARE WITHIN WHAT WOULD BE CONSIDERED ACCEPTABLE RANGE FOR A PATIENT WITH TWO METAL-ON-METAL REPLACEMENTS. PATIENT ELECTED TO PROCEED WITH A REVISION RIGHT TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHESIS, HIP, FEMORAL NECK KWY WRIGHT MEDICAL 5 4330 SN *
    2 * PROSTHESIS, HIP, FEMORAL HEAD KWY WRIGHT MEDICAL 38M5200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR