BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS CEMENTED FEMUR STANDARD

    MDR report key: 4206310 · Received October 23, 2014

    Report

    Report Number
    3005180920-2014-00140
    Event Type
    Injury
    Date Received
    October 23, 2014
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: EVOLIS STD FEMUR SIZE 4 RIGHT; REF 3010.204D/LOT #: 090383((B)(4) DEVICES PRODUCED AND ALL ALREADY SOLD WITHOUT ANY OTHER SIMILAR ISSUE REPORTED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, THE REVISED TIBIA HAS CODE 3031.0203, BUT WE HAVE NOT BEEN ABLE TO HAVE THE LOT NUMBER. THIS WAS THE TIBIA IMPLANTED DURING THE FIRST REVISION OF (B)(6) 2013. AT THAT TIME, THE REVISED TIBIA - THE ONLY COMPONENT REVISED WAS THE FOLLOWING: EVOLIS CEMENTED FIXED TIBIA TRAY SIZE 3: REF 3031.0203/ LOT #: 102119 ((B)(4) DEVICES PRODUCED AND (B)(4) SOLD WITHOUT ANY OTHER SIMILAR ISSUE REPORTED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED BUT BOTH THE REVISION SEEM TO BE LIKELY DUE TO A BAD CEMENTATION TECHNIQUE, THAT LED TO THE MOBILIZATION OF THE IMPLANTS.

    Description of Event or Problem · 1

    REF IMP #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677466 EVOLIS CEMENTED FEMUR STANDARD CEMENTED FIXED FEMUR SIZE 4 RIGHT JWH

    Patients

    Seq Age Sex Outcome Treatment
    1