BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HRHK TIB ROT COMP LRG/XLRG

    MDR report key: 1629263 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00285
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 16, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K994207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (USER RELATED) AND PRODUCT CODE KRO.

    Description of Event or Problem · 1

    USER RELATED. DURING A PROCEDURE, THE SALES REP NOTED THAT THE SURGEON IMPLANTED A MEDIUM MRH FEMUR IN COMBINATION WITH A ROTATING TIBIA COMPONENT 3MM OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HRHK TIB ROT COMP LRG/XLRG IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other