BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 23968427 · Received January 5, 2026

    Report

    Report Number
    1038671-2026-00010
    Event Type
    Injury
    Date Received
    January 5, 2026
    Report Date
    May 4, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-01-0325 - FEMUR PS CEM.Nº2.5 DER.: 5213253. 02-012-45-2515 - BANDEJA TIBIAL LOGIC FIT 2.5F/1.5T: 5452246. 200-02-32 - ROTULA TRES TETONES 32 MM: 5771922. 204-34-04 - VASTAGO EXT. 14 X 40 MM: 5705864. 204-70-00 - TORNILLO FIJACION VÁSTAGO A TIBIA: 5756547. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD TKAS IN BOTH KNEES, UNDERWENT A REVISION PROCEDURE ON THE RIGHT KNEE. IT WAS INDICATED THAT THE PROSTHESIS IS ON THE RECALL LIST. IT WAS ALSO INDICATED A FUTURE REVISION IS SCHEDULED FOR THE LEFT KNEE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298626 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1