BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 23360468 · Received October 22, 2025

    Report

    Report Number
    1038671-2025-03173
    Event Type
    Injury
    Date Received
    October 22, 2025
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2: (B)(6), 02-012-35-2015 - LOGIC TIBIA PS MOD INSRT SZ 2 15MM: (B)(6), 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T: (B)(6), 200-02-35 - THREE PEG PATELLA 35MM: (B)(6). THE REASON FOR THE JOINT SWELLING AND PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. 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 THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED SWELLING AND PAIN. AS A RESULT, THE PATIENT REPORTED THE NEED FOR A RIGHT KNEE REVISION SURGERY ON A FUTURE DATE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611692 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H11.