BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE STEM

    MDR report key: 2850924 · Received November 20, 2012

    Report

    Report Number
    2249697-2012-02414
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    June 1, 2010
    Report Date
    November 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT IS EXPERIENCING PAIN IN HIS UPPER THIGH AND STATES THAT THE PAIN COMES AND GOES IN HIS RIGHT BUTT CHEEK. PT IS REPORTING THAT PAIN THIS YEAR STARTED TO BECOME NOTICEABLE. PATIENT ALSO STATES THAT LAST WEEKEND PAIN WAS UNBEARABLE. PATIENT REPORTS THAT THE PAIN IN THE THIGH AREA IS A BURNING PAIN AND ALSO FEELS LIKE THIGH DOESN¿T WANT TO WORK. PATIENT STATES THAT HE IS SCHEDULED FOR BLOOD WORK AND MRI ON SATURDAY, (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other