BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2831107 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02153
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 26, 2010
    Report Date
    October 16, 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
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICE IMPLANTED, BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL 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 HAD BILATERAL HIP IMPLANTS IN 2010. THE PT REPORTS MUSCLE SPASMS AND PAIN IN HER LEFT HIP AFTER EXTENSIVE WALKING AND EXERTION. THE PAIN EXTENDS FROM HER HIP TO HER KNEE. THE PT STATES THAT IT IS PAINFUL TO LIE ON HER LEFT SIDE. ON (B)(6) 2012, THE PT HAD X-RAYS TAKEN. THE SURGEON ADVISED HER THAT NO PROBLEMS WERE EVIDENT. THE PT WAS TOLD TO FOLLOW-UP IN ONE YEAR UNLESS HER CONDITION WORSENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other