BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 22121866 · Received June 2, 2025

    Report

    Report Number
    3005180920-2025-00508
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825286
    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 16-MAY-2025: LOT 182058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 26-NOV-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 16-MAY-2025: GMK-HINGE 02.09.4005R FIXED TIBIAL TRAY SIZE 5 R (K130299) LOT 120937A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2017. EXPIRATION DATE: 13-NOV-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LOT FATHER 120937: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUL-2012. EXPIRATION DATE: 31-MAY-2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. GMK-HINGE 02.09.2605R FEMORAL COMPONENT SIZE 5 R (K130299) LOT 175671: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2017. EXPIRATION DATE: 23-NOV-2022. 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. 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

    AT ABOUT 4 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. NO ISSUE WITH THE IMPLANTS WAS DETECTED. THE SURGEON REVISED ALL GMK-HINGE COMPONENTS TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10232 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM KRO MEDACTA INTERNATIONAL SA 02.09.0517H 182058 07630030825286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention