BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 16099073 · Received January 4, 2023

    Report

    Report Number
    1038671-2023-00016
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 6, 2022
    Report Date
    February 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    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

    CONCOMITANTS: 6070497 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5, UNK 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, UNK 200-02-41 - THREE PEG PATELLA 41MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: H6: THE REVISION REPORTED WAS LIKELY THE RESULT OF TIBIAL INSERT WEAR. THE CAUSE OF THE WEAR COULD NOT BE DETERMINED BUT MAY HAVE BEEN DUE TO A COMBINATION OF THIRD BODY WEAR, ORIENTATION OF THE COMPONENTS, AND/OR PATIENT RELATED CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND IMAGES WERE NOT PROVIDED. ADDITIONALLY, THE INSERT WAS PACKAGED IN A NON-CONFORMING VACUUM BAG FOR FIVE YEARS, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED WEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2020, WAS REVISED ON (B)(6) 2022, APPROXIMATELY 2 YEARS 10 MONTHS POST THE INITIAL PROCEDURE DUE TO POLY WEAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING AS IT WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    RIGHT KNEE REVISION REPORTED UNDER 1038671-2023-00017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192966 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 9MM UNK 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10.