BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 23325851 · Received October 17, 2025

    Report

    Report Number
    1038671-2025-03143
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    January 25, 2024
    Report Date
    October 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6) - 02-010-01-0250 - LGC FEMORAL PS CEM LEFT SZ 5 (B)(6) - 02-012-43-5050 - LGC TIBIA RBKTRAY CEM SZ 5F/ 5T (B)(6) - 200-02-41 - THREE PEG PATELLA 41MM (B)(6) - 203-90-01 - 11-2624 POWERPRO SAWBLADE (B)(6) - 203-90-22 - (3118) HALL PWR PRO/VERS PWR PLUS 90X19X1.19MM SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 76 YO MALE PATIENT, WHO HAD AN INITIAL LEFT TKA, UNDERWENT A REVISION PROCEDURE 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
    2827873 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| H