BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 25160348 · Received May 13, 2026

    Report

    Report Number
    3005180920-2026-00444
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825484
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MAY 2026 GMK-HINGE 02.09.2605R GMK-HINGE FEMORAL COMPONENT R - SIZE5 (K130299) LOT. 2315255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2023. EXPIRATION DATE: 2028-SEP-16. 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 02.09.0612H GMK-HINGE TIBIAL INSERT - SIZE6 - 12 MM (K130299) LOT. 2215600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2022. EXPIRATION DATE: 2027-JUL-24. 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. ROOT CAUSE: 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

    REVISION SURGERY DUE TO A FRACTURED FEMUR AFTER ABOUT 2 MONTHS FROM PRIMARY AND THE CAUSE IS UNKNOWN. THE WAS NO INDICATION OF TRAUMA, BUT THE SURGEON DID NOTE POOR BONE QUALITY. THE SURGEON REVISED GMK-HINGE SIZE 5 FEMORAL COMPONENT TO A SAME SIZE FEMORAL COMPONENT AND REVISED THE GMK-HINGE 12MM INSERT TO A GMK-HINGE 14MM INSERT DUE TO LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571114 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE FEMORAL COMPONENT R - SIZE5 KRO MEDACTA INTERNATIONAL SA 02.09.2605R 2315255 07630030825484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention