BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2833003 · Received October 30, 2012

    Report

    Report Number
    2249697-2012-02125
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    April 26, 2012
    Report Date
    October 5, 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
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. DEVICE INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME. INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; PATIENT IS EXPERIENCING STRAIN WHEN EXERCISING. PATIENT IS ALSO EXPERIENCING PAIN ON THE LEFT SIDE BUT SAID IT WAS HER BACK. PATIENT IS REPORTING THAT SHE HAD X-RAYS AND BLOOD WORK DONE FOR HER BACK. PATIENT IS PLANNING TO GO TO HER SURGEON. PATIENT HAS THREATENED TO GET A LAWYER.

    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 34 YR Other