BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM

    MDR report key: 18181908 · Received November 21, 2023

    Report

    Report Number
    1038671-2023-02831
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    November 2, 2023
    Report Date
    May 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159281
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF 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. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION; (D10) CONCOMITANT DEVICE(S): 5777031 - 02-010-04-0235 - LOGIC CR FEMORAL POR, LEFT, SZ 3.5; 3933664 - 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T; 5939545 - 200-02-35 - THREE PEG PATELLA 35MM; 5719606 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 5776148 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK; S019825 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; S032419 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; S031429 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS; 6028019001 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF 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. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE 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 4 YEARS POST OP INITIAL LEFT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMUR LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122475 LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862159281

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female SEE H10.