BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE FEMUR SIZE 5 RIGHT

    MDR report key: 4143496 · Received August 21, 2014

    Report

    Report Number
    3005180920-2014-00110
    Event Type
    Injury
    Date Received
    August 21, 2014
    Manufacturer
    MEDACTA INTERNAIONAL SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    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 WASHING AND STERILIZATION PROCESSES: GMK HINGE CEMENTED FEMUR SIZE 5 RIGHT (K130299): CODE 02.09.2605R/ LOT 112424 ((B)(4) PRODUCED). GMK HINGE PE INSERT 10 MM SIZE 5 (THICKNESS NOT MARKETED IN THE USA): CODE 02.09.0510H/LOT 111327 ((B)(4) PRODUCED). GMK HINGE FIXED CEMENTED TIBIAL TRAY SIZE 5 RIGHT (K130299): CODE 02.09.4005R/LOT 113604 ((B)(4) PRODUCED). GMK REVISION/HINGE DISTAL FEMORAL WEDGE 8MM SIZE 5 (K102437): CODE 02.05.05DW/LOT 102555 ((B)(4)PRODUCED). GMK REVISION/HINGE POSTERIOR FEMORAL WEDGE 5MM SIZE 5 (K102437): CODE 02.05.05PW/LOT 102537 ((B)(4) PRODUCED). GMK REVISION/HINGE CEMENTLESS EXTENSION STEM 12 L 65 (K120790): CODE 02.07.FCL12065/LOT 124309 ((B)(4) PRODUCED). GMK REVISION/HINGE CEMENT LESS EXTENSION STEM 10 L 65 (K120790): CODE 02.07.FCL10065/LOT 115685 ((B)(4) PRODUCED). GMK REVISION/HINGE OFFSET 5 MM (K102437): CODE 02.07.0005/LOT 134659 ((B)(4) PRODUCED). GMK REVISION/HINGE TIBIAL AUGMENT 10MM SIZE 5 (K130299): CODE 02.09.TA510/ LOT 111158 ((B)(4) PRODUCED). ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505454 GMK HINGE FEMUR SIZE 5 RIGHT FIXED CEMENTED HIGNE FEMORAL COMPOENNT KRO MEDACTA INTERNAIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1