BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT HIP STEM

    MDR report key: 2896127 · Received December 27, 2012

    Report

    Report Number
    2249697-2012-02796
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    April 8, 2011
    Report Date
    December 10, 2012
    Manufacturer
    STRKER 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 PATIENT 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 THE PATIENT IS EXPERIENCING PAIN IN HIS RIGHT HIP. PATIENT HAS A LIMP AND STATES THAT HIS HIP DOESN¿T HOLD HIS WEIGHT. PATIENT STATES THAT HE HAS HAD BLOOD WORK AND MRI DONE. BLOOD WORK SHOWS ELEVATED LEVELS OF METAL. PATIENT ALSO STATES THAT HE IS GOING TO THE SURGEON TODAY TO BE TESTED AGAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other