BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 18788110 · Received February 27, 2024

    Report

    Report Number
    1038671-2024-00324
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 25, 2024
    Report Date
    October 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    Z-0026-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 5020842 - 02-010-01-0250 - LGC FEMORAL PS CEM LEFT SZ 5, 6352885 - 02-012-43-5050 - LGC TIBIA RBKTRAY CEM SZ 5F/ 5T, AND 6547588 - 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EVENT INVOLVED A DEVICE THAT IS NOT MARKETED IN THE UNITED STATES, NOR HAS A SIMILAR MARKETED DEVICE IN THE UNITED STATES. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA AND THIS REPORT MAY BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 76 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 5 MONTHS POST THE INITIAL PROCEDURE DUE TO INFECTION. THE SURGEON TOOK THE ENTIRE CONSTRUCT OUT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. NO DEVICE RETURNS WERE AVAILABLE AS THEY WERE DISCARDED. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656949 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC TIBIA PS RBK INSRT SZ 5 11MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention