BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 21574226 · Received March 11, 2025

    Report

    Report Number
    3005180920-2025-00150
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    March 11, 2025
    Report Date
    February 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825132
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-02-2025 LOT 2247581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-03-2023. EXPIRATION DATE: 2028-02-20. 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. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 17-02-2025 GMK-HINGE 02.09.2704L GMK-HINGE FEMORAL COMPONENT SIZE4 L - TINBN COATED (K210010) LOT 2311769: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-11-2023. EXPIRATION DATE: 2028-10-31. 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. DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338062 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE 02.09.0314H GMK-HINGE TIBIAL INSERT - SIZE3 - 14 MM KRO MEDACTA INTERNATIONAL SA 02.09.0314H 2247581 07630030825132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention