BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRN BCS II LCK FEM IMPLANT IMPACT

    MDR report key: 8034063 · Received November 2, 2018

    Report

    Report Number
    1020279-2018-02341
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 16, 2018
    Report Date
    May 7, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556003541
    PMA / PMN Number
    K111711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THIS EVENT WAS ALREADY REPORTED UNDER 1020279-2018-02353, THEREFORE THIS REPRESENTS A DUPLICATE COMPLAINT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THIS EVENT WAS ALREADY REPORTED UNDER 1020279-2018-02353, THEREFORE THIS REPRESENTS A DUPLICATE COMPLAINT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPACTING THE FEMUR IN THE PATIENT WITH THE INITIAL FEMUR IMPACTOR, THE SET SCREW SHEARED OFF THAT RELEASES THE IMPACTOR FROM THE IMPLANT AND WE COULD NOT GET THEM APART. THE SURGEON REMOVED THE INITIAL FEMUR WITH THE BROKEN IMPACTOR. THE REP OPENED UP A SPARE IMPACTOR AND A NEW IMPLANT WHICH THE SURGEON THEN IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872868 JRN BCS II LCK FEM IMPLANT IMPACT PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER JWH SMITH & NEPHEW, INC. 13EST0003 00885556003541

    Patients

    Seq Age Sex Outcome Treatment
    1