BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE AND REVISION TINBN COATED

    MDR report key: 23231345 · Received October 7, 2025

    Report

    Report Number
    3005180920-2025-00957
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K210010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2025: GMK-HINGE 02.09.4801R GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 1R (K210010) LOT 2217606: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2023. EXPIRATION DATE: 08-FEB-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. ADDITIONAL IMPLAINTS INVOLVED, BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2025: GMK-HINGE 02.07.FCL14105 FLUTED EXTENSION STEM Ø14MM / L 105MM (K120790) LOT 2304873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2023. EXPIRATION DATE: 24-JUL-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 02.07.FCL14150 FLUTED EXTENSION STEM Ø14MM / L 150MM (K120790) LOT 2242881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2023. EXPIRATION DATE: 04-MAR-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 02.09.2702R GMK-HINGE FEMORAL COMPONENT SIZE 2 R - TINBN COATED (K210010) LOT 2246364: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2023. EXPIRATION DATE: 23-AUG-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. CLINICAL EVALUATION: A REVISION SURGERY WAS PERFORMED APPROXIMATELY 1.5 YEARS AFTER THE IMPLANTATION OF A HINGED PROSTHESIS WITH EXTENSION STEMS AND SENSITIN COATING, DUE TO LOOSENING ON BOTH THE FEMORAL AND TIBIAL SIDES. THE AVAILABLE X-RAY IMAGES CLEARLY DEMONSTRATE RADIOLUCENT LINES AROUND BOTH THE FEMORAL AND TIBIAL STEMS, AS WELL AS SIGNS OF BONE REMODELING AT THE DISTAL FEMUR AND PROXIMAL TIBIA. MOREOVER, THE OSTEOTOMY OF THE ANTERIOR PROXIMAL TIBIA DOES NOT APPEAR TO HAVE HEALED. CONSIDERING THE EARLY OCCURRENCE OF THIS FAILURE, IT IS LIKELY THAT PROPER OSSEOINTEGRATION DID NOT TAKE PLACE. INFECTION WAS EXCLUDED, BUT THE EXACT CAUSE REMAINS UNCERTAIN; HOWEVER, IN SUCH COMPLEX CASES, THE LITERATURE OFTEN REPORTS THE ETIOLOGY AS MULTIFACTORIAL OR UNCLEAR. BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. CONCLUSION: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    REPLACEMENT OF KNEE PROSTHESIS HINGE IN PLACE ABOUT 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY FOR UNKNOWN REASONS. DURING THE REVISION, THE PROSTHESES WERE FOUND COMPLETELY DETACHED FROM THE BONE. REPLACEMENT WITH A SENSITIN HINGE (DUE TO NICKEL ALLERGY) WITH CONES ON THE FEMUR AND TIBIA. THE INFECTION SAMPLE GAVE A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746250 GMK HINGE AND REVISION TINBN COATED GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 1R JWH MEDACTA INTERNATIONAL SA 02.09.4801R 2217606

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention