BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP STEM

    MDR report key: 2896053 · Received December 27, 2012

    Report

    Report Number
    2249697-2012-02802
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    March 1, 2011
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 IS REPORTED THAT THE PATIENT HAS BILATERAL RECALLED IMPLANTS. THERE IS NO PAIN IN THE LEFT LEG AT THIS TIME. THE PATIENT BEGAN HAVING PAIN IN THE RIGHT GROIN, OUTSIDE OF THE HIP AND DOWN HER LEG IN (B)(6) 2012. THE PAIN IS CONSTANT AND INTENSE. PATIENT COMPLETED BLOOD TESTS AND AN MRI IN (B)(6) 2012 WHICH INDICATED THAT A REVISION IS NEEDED. PATIENT IS IN THE PROCESS OF SCHEDULING THE REVISION OF THE RIGHT HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other