BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM

    MDR report key: 18477832 · Received January 9, 2024

    Report

    Report Number
    1038671-2024-00052
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    December 14, 2023
    Report Date
    June 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230362
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF OSTEOLYSIS AND PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT. HOWEVER, IMAGES OF THE REVISED INSERT DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED, AND THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS - THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(6) - LOGIC CR FEMORAL POR, RIGHT, SZ 2.5 (CAT# 02-010-04-0325 / SERIAL#(B)(6) - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T (CAT# 02-012-45-2525 / SERIAL# (B)(6) ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    D10: (B)(6) 200-02-35 - THREE PEG PATELLA 35MM. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED IN CASE-2023-00011405 WAS LIKELY THE RESULT OF OSTEOLYSIS AND PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT. HOWEVER, IMAGES OF THE REVISED INSERT DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED, AND THE REVISED COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION. POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SEVEN MONTHS POST RIGHT TKA REVISION, THE 68 Y/O FEMALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AS WELL AS POLY WEAR AND DELAMINATION. THIS POLY WAS IN A CONFORMING BAG AND HAS ONLY BEEN IN SINCE (B)(6) 2023 BUT IT ALREADY SHOWED SIGNIFICANT DAMAGE. THE WEAR CHARACTERISTICS ARE THE SAME AS THE OTHER AFFECTED POLY¿S PITTING AND WEAR MARKS. ALL COMPONENTS WERE REMOVED. PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461850 LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM UNK 10885862230362

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R