BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM

    MDR report key: 18499081 · Received January 11, 2024

    Report

    Report Number
    1038671-2024-00083
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230485
    PMA / PMN Number
    K123342
    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

    REPORT NUMBER: 1038671-2024-03320 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8 H10 THE FOLLOWING SECTIONS WERE CORRECTED: B2 H6 THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF LOOSENING, PROSTHESIS WEAR, AND OSTEOLYSIS. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE. BASED ON THE IMAGES PROVIDED, THERE DOES NOT APPEAR TO BE EXCESSIVE WEAR OF THE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED 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 MAY HAVE BEEN THE RESULT OF LOOSENING, PROSTHESIS WEAR, AND OSTEOLYSIS. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE. BASED ON THE IMAGES PROVIDED, THERE DOES NOT APPEAR TO BE EXCESSIVE WEAR OF THE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 6607062 200-02-35 - THREE PEG PATELLA 35MM. 6636172 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4. 3604441 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H60 INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED MEDICAL DEVICE PROBLEM CODE AND COMPONENT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 53 Y/O FEMALE PATIENTS RIGHT KNEE WAS REVISED 1.5 YEARS POST OP. THE PATIENT WAS REVISED DUE TO OSTEOLYSIS, LOOSENING AND POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURN; DISPOSED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705870 LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862230485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10.