BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT HIP REJUVENATE STEM

    MDR report key: 2896135 · Received December 27, 2012

    Report

    Report Number
    2249697-2012-02807
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 11, 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
    UK
    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 IS REPORTED THAT: AS PER THE PATIENT¿S SPOUSE, THE PATIENT RELOCATED TO (B)(6) IN (B)(6)2012. THE PATIENT HAS BEEN EXPERIENCING SWELLING OF THE HIP, THIGH AND GROIN PAIN SINCE (B)(6) 2011. THE PAIN IS CONSTANT AND SEVERE. PATIENT ALSO REPORTS EXTREME FATIGUE AND NAUSEA. BLOOD TEST SHOWED ELEVATED METAL LEVELS. PATIENT WILL HAVE AN MRI AND ASPIRATION. PATIENT WAS ADVISED BY LOCAL PHYSICIAN TO CONTACT THE IMPLANT SURGEON REGARDING SYMPTOMS. PATIENT CALLED THE US SURGEON AND WAS TOLD OF THE RECALL. (B)(6) DOCTOR RECOMMENDS REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other