BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS CEMENTED STANDARD FEMUR SIZE 2 RIGHT

    MDR report key: 3716499 · Received February 19, 2014

    Report

    Report Number
    3005180920-2014-00012
    Event Type
    Injury
    Date Received
    February 19, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: EVOLIS CEMENTED FEMORAL COMPONENT SIZE 2 RIGHT: CODE 3031.202D / LOT P02-3653 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG; ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND ONE SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, THE PROBLEM OCCURRED IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    PT PRESENTED TO THE SURGEON IN 2013 COMPLAINING OF INCREASING PAIN TO PREVIOUSLY OPERATED KNEE. SURGEON REVISED KNEE ON (B)(6) 2014 FOR INCREASING PAIN DUE TO LOOSE FEMORAL COMPONENT. REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104049 EVOLIS CEMENTED STANDARD FEMUR SIZE 2 RIGHT FIXED STD FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1