BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2831071 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02172
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    April 29, 2010
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PT AND WAS NOT RETURNED TO THE MFR. DEVICE INFO HAS NOT BEEN PROVIDED AT THIS TIME. INFO RECEIVED FROM THE PT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCE IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PT SAW HIS ORTHOPEDIC SURGEON ABOUT 8 MONTHS AGO. AT THE TIME, X-RAYS OF THE HIP WERE TAKEN AND THE DOCTOR SAID EVERYTHING LOOKED FINE. THE PT STATES THAT HE BEGAN HAVING PAIN IN HIS HIP SIX WEEKS AFTER HIS SURGERY IN 2010 THAT CONTINUES TO THE PRESENT TIME. HE SAYS THAT HIS PAIN IS CONSTANT AND IS LOCATED IN THE GROIN AND RADIATES DOWN BOTH LEGS. THE PT TAKES 40 MG OXYCODONE TWICE DAILY TO MANAGE THE PAIN. THE PT SAYS THAT HE CAN BARELY WALK AND MUST USE A WALKER TO GET AROUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other