BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS CEMENTED FIXED FEMUR SIZE 4 LEFT

    MDR report key: 4297133 · Received November 14, 2014

    Report

    Report Number
    3005180920-2014-00157
    Event Type
    Injury
    Date Received
    November 14, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVOLIS CEMENTED STD FEMUR SIZE 4 LEFT: CODE 3010.204G/ LOT# 102080 ((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. EVOLIS CEMENTED FIXEX TIBIAL TRAY SIZE 3: CODE 3031.0203/ LOT# 123092 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. EVOLIS STD PE FIXEX INSERT SIZE 3, 11MM: CODE 3040.0311/ LOT# 081348 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. EVOLIS INSET PATELLA 24 MM: CODE 3050.0024/ LOT# 114680 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. A (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, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739035 EVOLIS CEMENTED FIXED FEMUR SIZE 4 LEFT KNEE CEMENTED FIXED FEMUR JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1