BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE FEMUR SIZE 2 RIGHT

    MDR report key: 4195528 · Received September 12, 2014

    Report

    Report Number
    3005180920-2014-00123
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 12, 2014
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS A GMK HINGE CASE WITH A LOT OF COMPONENTS. DOCUMENT REVIEWS HAVE BEEN PERFORMED FOR ALL THE LOTS OF THE ITEMS IMPLANTED WITHOUT FINDING ANY ISSUE RELATED TO THE EVENT: GMK HINGE CEMENTED FEMUR SIZE 2 RIGHT (K130299): CODE 02.09.2602R / LOT 120837 (B)(4). GMK HINGE PE INSERT 12 MM SIZE 2 (K130299): CODE 02.09.0212H / LOT 120010 (B)(4). GMK HINGE FIXED CEMENTED TIBIAL TRAY SIZE 2 RIGHT (K130299): CODE 02.09.4002R / LOT 120878 (B)(4). GMK REVISION/HINGE CEMENTLESS EXTENSION STEM 14 L 65 (K120790): CODE 02.07.FCL14065 / LOT 115709 (B)(4). GMK REVISION/HINGE CEMENTLESS EXTENSION STEM 11 L 65 (K120790): CODE 02.07.FCL11065 / LOT 115691 (B)(4). GMK REVISION/HINGE OFFSET 5 MM (K102437): CODE 02.07.0005 / LOT 131532 (B)(4). GMK REVISION HINGE OFFSET 3 MM (K102437): CODE 02.07.0003 / LOT 131531 (B)(4). GMK REVISION/HINGE TIBIAL AUGMENT 10MM SIZE 2 (K130299): CODE 02.09.TA210 / LOT 112181 (B)(4). ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565435 GMK HINGE FEMUR SIZE 2 RIGHT FIXED CEMENTED HINGE FEMORAL COMPONENT KRO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention