BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 6, 9MM

    MDR report key: 23929905 · Received December 30, 2025

    Report

    Report Number
    1038671-2025-03651
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    November 10, 2025
    Report Date
    February 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174642
    PMA / PMN Number
    K121307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-04-0260 - LOGIC CR FEMORAL POR, LEFT, SZ 6: (B)(6). 02-012-45-6060 - LGC TIBIAL FIT TRAY CEM SZ 6F / 6T: (B)(6). 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. PATIENT PRESENTED FOR A PATELLA RESURFACING PROCEDURE. DURING THE PROCEDURE THE SURGEON ALSO DECIDED TO EXTRACT AND REPLACE THE TIBIAL POLY LINER AS IT WAS PART OF THE TKR POLY LINER RECALL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836217 LOGIC CR TIB INSERT STD, SZ 6, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174642

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11