BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP NECK

    MDR report key: 2911043 · Received January 4, 2013

    Report

    Report Number
    9616680-2013-90037
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    February 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    KWA
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 IS REPORTED THAT, IN (B)(6) 2012, PATIENT BEGAN HAVING PERIODIC, DEBILITATING PAIN IN THE FRONT OF THE THIGH DOWN INTO THE LEG, AND DIFFICULTY LIFTING HER LEG. MRI AND BLOOD TEST SHOW FLUID ON THE HIP AND ELEVATED METAL LEVELS. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5332 UNKNOWN RIGHT HIP NECK IMPLANT KWA STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other