BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA HIP STEM #8

    MDR report key: 2555800 · Received February 5, 2010

    Report

    Report Number
    2249697-2010-01956
    Event Type
    Injury
    Date Received
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    K982032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B)(4) 2006 TO (B)(4) 2008, WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER (B)(4). THIS IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (DIMENSIONAL DISCREPANCY) AND PRODUCT CODE MEH.

    Description of Event or Problem · 1

    DIMENSIONAL DISCREPANCY. SURGEON REPORTED THAT HE HAS NOTICED A DIFFERENCE IN THE PROXIMAL BODY OF THE SECURFIT STEM AND THE SECURFIT MAX. HE HAS HAD ONE STEM SUBSIDE AND ONE FRACTURED CALCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIT HA HIP STEM #8 IMPLANT MEH STRYKER ORTHOPAEDICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other