BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2871894 · Received December 6, 2012

    Report

    Report Number
    2249697-2012-02549
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 1, 2011
    Report Date
    November 19, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS INFORMED OF THE RECALL DURING AN ANNUAL CHECK UP ON (B)(6) 2012. X-RAYS AND BLOOD WORK WERE PERFORMED. THE PATIENT'S COBALT LEVELS WERE ELEVATED. THE PATIENT HAS BEEN EXPERIENCING DISCOMFORT IN THE RIGHT BUTTOCKS FOR APPROXIMATELY TWO WEEKS. THE DISCOMFORT IS NOT CONSTANT OR DEBILITATING. THE PATIENT IS SCHEDULING A FOLLOW-UP APPOINTMENT WITH THE SURGEON FOR ADDITIONAL TESTING IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA WLXMED

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other