BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2821386 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-01978
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    March 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATES THAT SHE HAS BEEN IN PAIN SINCE THE TIME OF IMPLANT. SHE IS VERY STIFF IN THE MORNING AND REQUIRES MEDICATION TO FUNCTION. SHE IS ON HER FEET MOST OF HER WORK DAY. SHE SAW HER PHYSICIAN APPROXIMATELY (B)(6) WEEKS AGO. SHE HAD TAKEN BLOOD WORK FOR METAL/IRON LEVELS. THE TEST RESULTS SHOWED HIGH METAL LEVELS FOR COBALT. THE SURGEON HAS DETERMINED THAT, IF LEVELS INCREASE, SHE WILL NEED REVISION SURGERY. SHE IS BEING MONITORED AND WILL HAVE ANOTHER BLOOD WORK TEST IN 6 WEEKS. SHE HAS ALSO LOST SIGNIFICANT RANGE OF MOTION AND IS EXPERIENCING INTENSE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT HIP IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other