BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 22923098 · Received August 29, 2025

    Report

    Report Number
    3005180920-2025-00808
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825217
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-08-2025. LOT 181588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-06-2018 EXPIRATION DATE: 2023-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED AND REVISED: GMK-HINGE 02.09.2604L GMK-HINGE FEMORAL COMPONENT L - SIZE 4 LOT 2105184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2021 EXPIRATION DATE: 2026-AUG-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09.4004L FIXED TIBIAL TRAY SIZE 4 L LOT 1910587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2020 EXPIRATION DATE: 2025-FEB-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 4 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2870697 GMK HINGE TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SIZE 4/17MM KRO MEDACTA INTERNATIONAL SA 02.09.0417H 181588 07630030825217

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention