BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK STANDARD CEMENTED FEMUR SIZE 5 LEFT

    MDR report key: 3547294 · Received December 19, 2013

    Report

    Report Number
    3005180920-2013-00180
    Event Type
    Injury
    Date Received
    December 19, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY CEMENTED STD FEMUR SIZE 5 LEFT: CODE (B)(4)/LOT 122101 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THIRTY-ONE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK PRIMARY CEMENTED MOBILE TIBIAL TRAY SIZE 5 L - NOT MARKETED IN THE USA: CODE (B)(4)/LOT 122806 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THIRTY-THREE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK PRIMARY STD MOBILE TIBIAL INSERT SIZE 5, 12 MM - NOT MARKET IN THE USA: CODE (B)(4)/LOT 114101 ((B)(4) ITEMS PRODUCTED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (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 IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666171 GMK STANDARD CEMENTED FEMUR SIZE 5 LEFT FIXED STD FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1