BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY IMPRINT PS

    MDR report key: 18317641 · Received December 13, 2023

    Report

    Report Number
    3004153240-2023-00041
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 12, 2023
    Manufacturer
    CONFORMIS, INC
    Product Code
    JWH
    PMA / PMN Number
    K221404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 21 NOV 2023 (B)(4) FROM A CONFORMIS SALES REPRESENTATIVE STATING THAT THE TIBIAL TRAY IMPLANT WAS INCORRECT. THE PACKAGE OF THE IMPRINT TRAY LOT NUMBER 972242 SHOULD'VE CONTAINED A SIZE 7 PS IMPRINT TRAY IMPLANT BUT CONTAINED A SIZE 7 CR TRAY. THE ERROR WAS NOT IDENTIFIED UNTIL AFTER THE CR TIBIAL TRAY AND PS FEMORAL IMPLANTS WERE BOTH CEMENTED IN PLACE. A SOFT CLOSE WAS DONE WITH THE PLAN TO COMPLETE THE SURGERY THE NEXT DAY. THE MODIFIED PS TRIAL WAS LEFT IN THE PATIENT WITH THE SOFT CLOSE. THE SECOND SURGERY WAS CONDUCTED ON (B)(6) 2023, WITH A CS INSERT IMPLANTED. SECOND SURGERY WITH CS INSERT WAS SUCCESSFUL. THERE ARE SEVERAL ASSIGNABLE ROOT CAUSES FOR THIS FIELD COMPLAINT: HUMAN ERROR WHEN PROGRAMMING THE IMPRINT TRAY ENGRAVING PROGRAMS. FAILURE OF FOLLOWING THE VALIDATED AND CONTROLLED QC INSPECTION PROCESS IN (B)(4). HUMAN ERROR WHEN PRINTING THE INTEROFFICE LABEL PER(B)(4). SYSTEM ERROR OF NON-ACTIVE LABEL STAYING IN WORK ORDER IN SAP SYSTEM. VISUAL INSPECTION FAILURES OCCURRING IN QC AND IN THE CLEANROOM WHEN INSPECTING AND PACKAGING THIS IMPRINT CR TRAY WITH LABELING OF AN IMPRINT PS TRAY.

    Description of Event or Problem · 0

    IDENTITY IMPRINT PS PRODUCT CONTAINED IDENTITY IMPRINT CR TIBIAL TRAY. PS FEMUR AND CR TIBIAL TRAY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581226 IDENTITY IMPRINT PS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH CONFORMIS, INC 972242D

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Other