BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2831163 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02219
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    April 6, 2011
    Report Date
    October 17, 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 PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STATES, SHE HAS HAD TREMENDOUS BACK PAIN AND VARIOUS OTHER COMPLICATIONS SINCE THE IMPLANT. WITHIN ONE WEEK OF THE IMPLANT, SHE DEVELOPED A HEMATOMA THAT REQUIRED ADDITIONAL SURGERY AND HEAVY DOSE OF ANTIBIOTICS. SHE HAS A RASH AROUND THE INCISION SITE THAT PERIODICALLY FLARES UP AND ITCHES PROFUSELY. THE PT HAS HAD INTENSIVE BACK PAIN SINCE THE IMPLANT SURGERY. SHE STATES THAT SHE HAS BEEN ON NARCOTIC PAIN MEDICATIONS SINCE THE SURGERY AND IS NOT BEING TREATED BY A PAIN MGMT SPECIALIST. SHE WILL BE CONTACTED BY HER SURGEON WHEN TEST RESULTS ARE RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other