BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 22961215 · Received September 4, 2025

    Report

    Report Number
    3005180920-2025-00839
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825422
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 AUG 2025. GMK-HINGE 02.09.2602R GMK-HINGE FEMORAL COMPONENT R - SIZE2 (K130299) LOT 2100750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2021. EXPIRATION DATE: 2026-APR-29. 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. ADDITIONAL DEVICES INVOLVED: GMK-HINGE 02.09.4002R GMK-HINGE TIBIAL TRAY - 2R (K130299) LOT 2013006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2021. EXPIRATION DATE: 2026-APR-13. 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. GMK-HINGE 02.07. FCL15065 FLUTED EXTENSION STEM Ø15MM / L 065MM (K120790) LOT. 2100203: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2021. EXPIRATION DATE: 2026-JUN-14. 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. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIR DEPARTMENT: A REVISION SURGERY WAS PERFORMED APPROXIMATELY FOUR YEARS AFTER THE IMPLANTATION OF A HINGED KNEE PROSTHESIS, DUE TO ASEPTIC LOOSENING. THE AVAILABLE RADIOGRAPHIC IMAGES CLEARLY DEMONSTRATE SIGNS OF IMPLANT MOBILIZATION, PARTICULARLY EVIDENT AS RADIOLUCENT LINES AROUND THE FEMORAL STEM OF THE PROSTHESIS. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE, OFTEN ASSOCIATED WITH MULTIFACTORIAL OR UNCLEAR ETIOLOGY. IN THIS CASE AS WELL, THE EXACT CAUSE OF FAILURE IS DIFFICULT TO DETERMINE BASED ON THE AVAILABLE INFORMATION. HOWEVER, THERE ARE NO ELEMENTS TO SUGGEST A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO ASEPTIC LOOSENING OF PRIMARY HINGE PROTHESIS WITH UNCEMENTED STEMS AT 3 YEARS 10 MONTHS FROM PRIMARY. NO RECUTTING OF THE TIBIA AND FEMUR. REIMPLANTATION OF THE HINGE SYSTEM WITH CEMENTED COMPONENTS AND SENSITIN IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334681 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE FEMORAL COMPONENT R - SIZE2 KRO MEDACTA INTERNATIONAL SA 02.09.2602R 2100750 07630030825422

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention