BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE/AGBII HIP

    MDR report key: 2821541 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-02014
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    March 2, 2010
    Report Date
    October 5, 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
    MS, 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. AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTS THAT SHE HAS HAD PAIN PERIODICALLY SINCE THE SURGERY. THE PAIN IS NOT OVERWHELMING BUT IT DOES BOTHER HER. SHE HAS BEEN HAVING BACK PAIN ON THE RIGHT SIDE AND BELIEVES IT MAY BE ATTRIBUTABLE TO HER HIP IMPLANT. SHE CAN'T LAY ON HER RIGHT SIDE VERY LONG WITHOUT EXPERIENCING PAIN. SHE HAS PAIN AND DIFFICULTY WHEN GETTING INTO HER VEHICLE. SHE ALSO NOTICES THAT IT HURTS WHEN SHE STANDS FROM A SITTING POSITION OR JUST WHEN SHE MOVES A CERTAIN WAY. SHE IS UNDERGOING PHYSICAL THERAPY FOR HER HIP AND BACK WHICH IS VERY PAINFUL. SHE STATES THAT SHE WAS UNABLE TO FOLLOW THROUGH WITH THE PHYSICAL THERAPY ONE DAY BECAUSE OF THE PAIN IN HER HIP. SHE HAS NOT YET SEEN HER SURGEON AND WILL SCHEDULE AN APPOINTMENT SOON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other