BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3881979 · Received June 18, 2014

    Report

    Report Number
    0002249697-2014-02357
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    PMA / PMN Number
    K122853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN BROACH CAT. 1601-4005A LOT 9800-A4. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY USING SECUREFIT ADV STEM, SURGEON BROACHED TO A SIZE 5 WITH TIGHT FILL, WENT TRIED TO PUT STEM IN UPON INSERTION IT FELL BELOW THE CALCAR RESECTION. THE USE OF THIS STEM WAS ABANDON, SURGEON TRIED ANOTHER SIZE 5 WITH SAME RESULTS. THEN SURGEON BROACHED TO SIZE 6 SECUREFIT ADVANCE, BUT BROACH WAS TOO BIG FOR THE PATIENT SO SECUREFIT ADV STEM WAS ABANDONED AND SURGEON WENT TO THE J-SECUREFIT PLUS SIZE 7 AND IMPLANTED THAT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359298 UNKNOWN_RECONSTRUCTIVE_PRODUCT INSTRUMENT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other