BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT NORMALIZED HIP STEM

    MDR report key: 3844773 · Received June 3, 2014

    Report

    Report Number
    0002249697-2014-02031
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K932519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    HIP REVISION - STEM WAS LOOSE PROXIMALLY AND NEEDED TO BE REPLACED. THE SURGEON PERFORMED AN EXTENDED TROCHANTERIC OSTEOTOMY TO GET THE STEM OUT. THE CUP WAS WELL FIXED AND IN GOOD POSITION, THEREFORE IT WAS LEFT ALONE. WE REPLACED THE STEM WITH A RESTORATION MODULAR REVISION STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324602 OMNIFIT NORMALIZED HIP STEM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 Required Intervention