BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE AND REVISION TINBN COATED

    MDR report key: 24674593 · Received March 24, 2026

    Report

    Report Number
    3005180920-2026-00237
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040721844
    PMA / PMN Number
    K210010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MARCH 2026. GMK-HINGE 02.09.2703R GMK-HINGE FEMORAL COMPONENT SIZE3 R - TINBN COATED (K210010) LOT 2010969: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2021. EXPIRATION DATE: 07-FEB-2026. 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 02.07. FCL16105 FLUTED EXTENSION STEM D 16MM / L 105MM (K120790) LOT 177672B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2023. EXPIRATION DATE: 04-APR-2028. 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 02.09.0414H GMK-HINGE TIBIAL INSERT - SIZE4 - 14 MM (K130299) LOT 2219279: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2022. EXPIRATION DATE: 31-AUG-2027. 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: THE AVAILABLE X-RAY IMAGE REFERS TO THE TWO-WEEK POSTOPERATIVE PERIOD FOLLOWING THE INITIAL IMPLANTATION OF THE HINGED PROSTHESIS. FROM THIS PROJECTION, THE IMPLANT APPEARS TO BE IN A SATISFACTORY POSITION. NO POTENTIAL FAILURE MECHANISM CAN BE IDENTIFIED FROM THIS IMAGE, CONSIDERING THAT THE LOOSENING WAS REPORTED APPROXIMATELY THREE YEARS LATER. IN GENERAL, ASEPTIC LOOSENING IS A WELL-DESCRIBED ADVERSE EVENT IN THE LITERATURE FOLLOWING TKA, PARTICULARLY IN REVISION CASES, AND ITS CAUSES ARE OFTEN MULTIFACTORIAL OR UNKNOWN. IN THE PRESENT CASE, THE AVAILABLE INFORMATION IS INSUFFICIENT TO DETERMINE THE ROOT CAUSE. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR IMPLANTS. ON (B)(6) 2023, THE PATIENT WAS REVISED FROM COMPETITOR PRODUCTS TO MEDACTA GMK-HINGE. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME PRESENTING INSTABILITY DUE TO FEMORAL AND STEM LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-HINGE FEMORAL COMPONENT TO A SAME SIZE FEMORAL COMPONENT, THE GMK-HINGE 14MM INSERT TO A 17MM INSERT FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738393 GMK HINGE AND REVISION TINBN COATED GMK-HINGE FEMORAL COMPONENT SIZE3 R - TINBN COATED JWH MEDACTA INTERNATIONAL SA 02.09.2703R 2010969 07630040721844

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention