BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP STEM

    MDR report key: 2850954 · Received November 20, 2012

    Report

    Report Number
    2249697-2012-02404
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    March 26, 2012
    Report Date
    November 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED, THE PT WAS APPRISED OF THE RECALL ON (B)(6) 2012 DURING HER 6 MONTH CHECK-UP. BLOOD LABS WERE COMPLETED AT THAT TIME. THE PT STATES THAT SHE BEGAN HAVING PAIN IN THE FRONT OF THE UPPER PART OF THE LEFT THIGH ON (B)(6) 2012. THE PAIN IS NOT CONSTANT AND IS ASSOCIATED WITH CERTAIN MOVEMENTS. THE BASE OF THE IMPLANT SCAR IS TENDER WHEN PRESSURE IS APPLIED. THE PT HAS PROBLEMS SLEEPING ON THE LEFT SIDE BECAUSE OF A THROBBING PAIN WHICH SHE DESCRIBES AS AN OVERALL ACHE. THE PT SAYS THE THIGH AND HIP HURT WHEN SHE PUTS WEIGHT ON IT AND THAT SHE RECENTLY DEVELOPED A LIMP. THE PT WAS EXAMINED BY HER SURGEON ON (B)(6) 2012. AN MRI IS SCHEDULED FOR (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R