BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE SYSTEM

    MDR report key: 16312824 · Received February 7, 2023

    Report

    Report Number
    1038671-2023-00115
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    January 20, 2023
    Report Date
    November 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL DEVICES: (B)(4) 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5. (B)(4) 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. (B)(4) 02-012-51-5009 - LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM. RECALL #Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE DISLOCATION WITH LIKELY PATELLA TENDON RUPTURE AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT CONDITIONS. THERE IS NO OTHER PATIENT MEDICAL HISTORY AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, THIS 74 YEAR OLD MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO PATELLA DISLOCATION. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927546 LOGIC KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 200-02-41 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H SEE H10