BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #2.5 30MM 118MM

    MDR report key: 2850916 · Received November 20, 2012

    Report

    Report Number
    2249697-2012-02419
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    July 1, 2010
    Report Date
    October 25, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICE LISTED IN THIS REPORT: CAT #2043C-3250, LOT # 33378601, DESCRIPTION: CROSSFIRE) DEG INSERT. CAT #6260-9-332, LOT # 33054702, DESCRIPTION: 32MM +8 LFIT V40 HEAD. CAT # 2051-2050, LOT # MJJ68Y, DESCRIPTION: SECUR-FIT HA PSL CUP/CLUSTR SHELL 50MM. CAT #2020-6525-1, LOT # MHK736, DESCRIPTION: 6.5 BONE SCREW 25MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT¿S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STATES THAT HER HIP HURTS DOWN THE INSIDE OF THE RIGHT LEG. SHE HAS ALWAYS HAD PAIN SINCE THE SURGERY. THE PAIN HAS INTENSIFIED OVER TIME AND IS NOW CONSTANT AND SEVERE. SHE RECEIVES TREATMENT AT A PAIN MANAGEMENT CLINIC A FEW TIMES A WEEK. THE PT TAKES PAIN MEDICATION TWICE DAILY TO LESSEN THE PAIN. THE PT WAS LAST EXAMINED BY HER SURGEON IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE TMZF HIP STEM #2.5 30MM 118MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 32980005

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other