BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM

    MDR report key: 18853045 · Received March 6, 2024

    Report

    Report Number
    1038671-2024-00420
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 7, 2024
    Report Date
    May 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173645
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 3766400 - 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4. 3795289 - 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 3832369 - 200-02-35 - THREE PEG PATELLA 35MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN DUE TO ORIENTATION OF THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, OR ANY COMBINATION OF THESE WHICH LED TO WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1; B2; D1; H6. THE REVISION REPORTED MAY HAVE BEEN DUE TO ORIENTATION OF THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, OR ANY COMBINATION OF THESE WHICH LED TO WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. 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

    IT WAS REPORTED THAT A 82 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR AS WELL AS FLAKING AND DELAMINATION. THE PATIENT WAS REVISED TO A 38MM PATELLA, AND THE TIBIAL INSERT WAS REVISED TO A SZ 4, 11MM. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT WHICH THE SURGEON REMOVED. X-RAYS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THE SURGEON KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534719 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM SEE H10 JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM UNK 10885862173645

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| H