BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL SHELL SIZE 58

    MDR report key: 1622630 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00693
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    October 18, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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). THERE ARE 11 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 FUNCTIONED AS EXPECTED. IT WAS REPORTED BY PT, "SQUEAKING HIP. VERY NOISY WHEN STANDING/SITTING, BASIC MOVEMENTS. NO PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL SHELL SIZE 58 IMPLANT MEH STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other