BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    MDR report key: 22009376 · Received May 13, 2025

    Report

    Report Number
    1038671-2025-02044
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001214
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. THE REPORTED FEMORAL LOOSENING MAY HAVE BEEN CAUSED BY THE MALALIGNMENT BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL INSERT, HOWEVER, FEMORAL LOOSENING COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES. H10 RELATED REPORT NUMBERS: 1038671-2025-02045, 1038671-2025-02170, 1038671-2025-02171 AND 1038671-2025-02172.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 2988967 02-012-35-2011 LOGIC TIBIA PS MOD INSRT SZ 2 9MM. 5027290 200-02-32 - THREE PEG PATELLA 32MM. 2061881 02-012-45-2010 - LGC TIBIAL FIT TRAY CEM SZ 2F / 1T. 4930212 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. 4966702 204-70-00 - TIBIAL STEM EXT. SCREW. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED APPROXIMATELY 175 MONTHS POST A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN AND APPROXIMATELY A WEEK LATER UNDERWENT SCHEDULED A SECOND RIGHT KNEE REVISION PROCEDURE OF THE FEMORAL COMPONENT INSERT AND PATELLA COMPONENTS. IT WAS NOTED THE INSERT AND PATELLA WERE REPLACED DUE TO RECALLS AND THE FEMORAL COMPONENT WAS SIGNIFICANTLY LOOSE. PICTURES OF THE EXPLANTS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR MEDICAL INTERVENTIONS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414343 LOGIC FEMORAL PS CEM RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001214

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H