BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT HIP STEM

    MDR report key: 2893448 · Received December 21, 2012

    Report

    Report Number
    2249697-2012-02784
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    July 18, 2011
    Report Date
    December 6, 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
    PA, 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. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PT IS CURRENTLY EXPERIENCING PAIN IN HIS GROIN AREA. PT STATES THAT PAIN STARTED OVER THE (B)(6) OF 2012. IT HAS SINCE BECOME CONSTANT. PT HAS SEEN HIS SURGEON AND IS TO SCHEDULED A MARS MRI AND BLOOD WORK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other