BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, LEFT, SZ 5

    MDR report key: 18420577 · Received December 29, 2023

    Report

    Report Number
    1038671-2023-03080
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    November 30, 2023
    Report Date
    January 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158284
    PMA / PMN Number
    K123687
    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) 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; 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 4800237.

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) HEALTH EFFECT CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-03058 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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.

    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
    1708833 LOGIC CR FEMORAL POR, LEFT, SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862158284

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R