BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    MDR report key: 18300091 · Received December 11, 2023

    Report

    Report Number
    1038671-2023-02955
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 17, 2023
    Report Date
    April 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174444
    PMA / PMN Number
    K111400
    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

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED 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.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 3863653 - 02-010-04-0240 - LOGIC CR FEMORAL POR, LEFT, SZ 4; 3614034 - 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; 2865602 - 02-012-47-4009 - LOGIC CR TIB INSERT STD, SZ 4, 9MM; 3983051 - 200-02-35 - THREE PEG PATELLA 35MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS MALE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED AT HOSPITAL. UNABLE TO OBTAIN PHOTOS/X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137766 LOGIC CR TIB INSERT STD, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862174444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R