BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 23920103 · Received December 30, 2025

    Report

    Report Number
    3005180920-2025-01343
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 22, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825149
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-DEC-2025. GMK-HINGE 02.09.0317H GMK-HINGE TIBIAL INSERT - SIZE3 - 17 MM (K130299) LOT. 2118881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2022 EXPIRATION DATE: 2027-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09.2603L GMK-HINGE FEMORAL COMPONENT L - SIZE3 (K130299) LOT. 2418910: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2024 EXPIRATION DATE: 2029-10-21. 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 02.09.4003L GMK-HINGE TIBIAL TRAY - 3L (K130299) LOT. 2419492: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2024 EXPIRATION DATE: 2029-11-12. 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 02.12. E001RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S1 (K202022) LOT. 2507457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2025 EXPIRATION DATE: 2030-05-11. 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. 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

    AT ABOUT 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327049 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE TIBIAL INSERT - SIZE3 - 17 MM KRO MEDACTA INTERNATIONAL SA 02.09.0317H 2118881 07630030825149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention