BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 25160341 · Received May 13, 2026

    Report

    Report Number
    3005180920-2026-00421
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825194
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MAY 2026 GMK-HINGE 02.09.0412H GMK-HINGE TIBIAL INSERT - SIZE4 - 12 MM (K130299) LOT. 2337559: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 2028-NOV-20. 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 02.09.2605R GMK-HINGE FEMORAL COMPONENT R - SIZE5 (K130299) LOT. 2315255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2023. EXPIRATION DATE: 2028-SEP-16. 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 02.09.4004R GMK-HINGE TIBIAL TRAY - 4R (K130299) LOT. 2340878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2024. EXPIRATION DATE: 2029-FEB-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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

    REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS TO ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519065 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE TIBIAL INSERT - SIZE4 - 12 MM KRO MEDACTA INTERNATIONAL SA 02.09.0412H 2337559 07630030825194

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention