BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS CONNECTION PIECE RHT 80MM

    MDR report key: 1620586 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00265
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    October 10, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDICS
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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) (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 (REVISION SURGERY REQUIRED) AND PRODUCT CODE KRO.

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED. IT WAS REPORTED THAT "THE PATIENT HAD A GMRS SMALL DISTAL FEMUR WITH CEMENTED STEM. SURGEON REVISED IT TO A GMRS TOTAL FEMUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMRS CONNECTION PIECE RHT 80MM IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDICS NA L4IPX1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention