BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT HIP STEM

    MDR report key: 2893454 · Received December 21, 2012

    Report

    Report Number
    2249697-2012-02775
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 7, 2011
    Report Date
    December 6, 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
    MN, 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 IS REPORTED THAT THE PT RECEIVED A RECALL NOTIFICATION. THE PT OCCASIONALLY HAS PAIN IN HIS RIGHT BUTTOCK AND HIP JOINT. THE PT HAD AN MRI AND BLOOD TEST. BLOOD TEST SHOWED ELEVATED COBALT LEVELS. THE PT STATES THE SURGEON RECOMMENDS REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other