BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED CEMENTED TIBIAL TRAY SIZE 4 RIGHT

    MDR report key: 3546289 · Received November 27, 2013

    Report

    Report Number
    3005180920-2013-00154
    Event Type
    Injury
    Date Received
    November 27, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY CEMENTED FIXED TIBIAL TRAY SIZE 4 RIGHT. CODE 02.07.1204R / LOT 121940 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK PRIMARY PS FIXED TIBIAL INSERT SIZE 4, 10 MM. CODE 02.07.0410PSF / LOT 121129 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK PRIMARY CEMENTLESS PS FEMUR SIZE 4 RIGHT (NOT MARKETED IN THE USA): CODE 02.07.2104R / LOT 121002 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, THE INFECTION IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619332 GMK FIXED CEMENTED TIBIAL TRAY SIZE 4 RIGHT FIXED TIBIAL BASE PLATE JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1