BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE MEDICAL METAL ON METAL HIP

    MDR report key: 2296530 · Received October 10, 2011

    Report

    Report Number
    MW5022605
    Event Type
    Other
    Date Received
    October 10, 2011
    Report Date
    October 10, 2011
    Manufacturer
    ENCORE - DJO SURGICAL
    Product Code
    KWA
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SWELLING PAIN, AND DECREASED MOBILITY WITH INCREASED BLOOD SERUM COBALT. SINCE TOTAL HIP REPLACEMENT (2004 PT. (B)(6)) WITH ENCORE (NOW DJO SURGICAL) METAL ON METAL HIP, HAVE HAD INCREASING PAIN, AND SWELLING REQUIRING OCCASIONAL NARCOTIC PAIN CONTROL MEDICATIONS. CONTINUED AND FREQUENT PAIN AND SWELLING AT THIS POINT, ELEVATED SERUM COBALT 10.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE MEDICAL METAL ON METAL HIP PROSTHETIC HIP KWA ENCORE - DJO SURGICAL METAL ON METAL ENCORE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other