BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 9MM

    MDR report key: 20057238 · Received August 23, 2024

    Report

    Report Number
    1038671-2024-03058
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    November 30, 2023
    Report Date
    January 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-012-47-5009 - LOGIC CR TIB INSERT STD, SZ 5, 9MM: 3850485 200-02-38 - THREE PEG PATELLA 38MM 4848517.

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2023-03080 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE FOLLOWING SECTIONS WERE CORRECTED: B2 D4: EXPIRATION DATE D10 CONCOMITANTS: 200-02-38 - THREE PEG PATELLA 38MM (B)(6), 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T (B)(6). H4 THE REVISION REPORTED WAS LIKELY THE RESULT OF FEMORAL LOOSENING AND TIBIAL INSERT WEAR. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE. THE TIBIAL INSERT WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, THIRD BODY WEAR, PATIENT RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF FEMORAL LOOSENING AND TIBIAL INSERT WEAR. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE. THE TIBIAL INSERT WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, THIRD BODY WEAR, PATIENT RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME. (D4) CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, UNIQUE IDENTIFIER (UDI) #. (H4) DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL LEFT TSA, THIS 60 Y/O MALE PATIENT WAS REVISED. THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AND OSTEOLYSIS AS A RESULT OF POLY WEAR. THE PATIENT WAS REVISED TO A SIZE 5 FEMORAL COMPONENT AND A SIZE 5 13MM TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482279 LOGIC CR TIB INSERT STD, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11