BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECUR-FIT HA HIP STEM #10

    MDR report key: 1621876 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00965
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    July 7, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    K982032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE ARE 5 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED) AND PRODUCT CODE MEH.

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED BY PATIENT, BY PHONE THAT "CERAMIC SQUEAK, INCREASING IN FREQUENCY. STARTED APPROXIMATELY ONE YR AGO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIT HA HIP STEM #10 IMPLANT MEH STRYKER ORTHOPAEDICS NA U6586301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other