BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM

    MDR report key: 17215636 · Received June 28, 2023

    Report

    Report Number
    1038671-2023-01482
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 19, 2023
    Report Date
    January 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230324
    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

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, IMAGES OF THE REVISED COMPONENTS DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED, NO RADIOGRAPHS WERE PROVIDED, AND THE REVISED COMPONENT WAS NOT RETURNED TO EXACTECH FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B4) DESCRIBE EVENT OR PROBLEM: AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL LEFT TKA, THIS 70 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. PATELLA AND LINER WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING - DISPOSED AT THE HOSPITAL. (H6) COMPONENT CODE: 734, BEARINGS.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): (B)(6), A10012 - GPS IMPLANT KIT V2; (B)(6), 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; (B)(6), 02-010-04-0220 - LOGIC CR FEMORAL POR, LEFT, SZ 2; (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK; (B)(6), 200-02-32 - THREE PEG PATELLA 32MM; (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; (B)(6), 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS; (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL LEFT TKA, THIS 70 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. PATELLA AND LINER WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING - DISPOSED AT THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FROM AUSTRALIA HAS BEEN SCHEDULED FOR LEFT TKA REVISION SURGERY. REVISION HAS NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724900 LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862230324

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown SEE H10