BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    MDR report key: 19095095 · Received April 12, 2024

    Report

    Report Number
    1038671-2024-00818
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 4, 2024
    Report Date
    August 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 4443409 - 02-012-44-2009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM. 6309086 - 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 6385475 - 200-02-32 - THREE PEG PATELLA 32MM. 6663921 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 6660789 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK . S005855 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S011086 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S041438 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. 3009220031 - A10012 - GPS IMPLANT KIT V2. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H2: THE REASON FOR THE REVISION IN CASE-(B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND FEMORAL LOOSENING AS REPORTED, PATIENT CONDITIONS, OR INCLUSION OF THE IMPLANTED POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO FEMUR LOOSENING FROM POLY, AND PATELLA WEAR. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808872 LOGIC FEMORAL PS CEM RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention