BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE COMPONENTS

    MDR report key: 20498294 · Received October 21, 2024

    Report

    Report Number
    1038671-2024-04061
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. B3: DATE OF EVENT IS UNKNOWN. CONCOMITANTS: 200-05-26 - INSET PATELLA 26MM 0733831. 200-24-09 - CR TIBIAL INSERT SZ4, 9MM 0806623. 200-04-44 - CEMENTED FINNED TIB. TRA SZ 4F/4T 0842739. 200-01-04 - CEMENTED CR FEMORAL SZ 4 7833087.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY (TKA) REVISION ON AN UNSPECIFIED DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202948 UNKNOWN KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention