BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL FEM COMP STD

    MDR report key: 1629237 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00271
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    December 18, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) (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 IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USE) AND PRODUCT CODE KRO.

    Description of Event or Problem · 1

    DEVICE BROKE OR DISASSEMBLED DURING USE. IT WAS REPORTED THAT A PIECE OF THE IMPLANT HAS PULLED OFF AND IS SITTING LOOSE IN THE JOINT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMAL FEM COMP STD IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other