BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23291023 · Received October 15, 2025

    Report

    Report Number
    3005180920-2025-00990
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815607
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2025: GMK-REVISION 02.07.0510SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 10 MM (K103170) LOT 2116751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2022. EXPIRATION DATE: 2027-01-06. 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-REVISION 02.07.0685L REVISION TIBIAL TRAY SIZE 5 LEFT - FINISHING (K123721) LOT 2341790: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2024. EXPIRATION DATE: 2029-01-23. 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-REVISION 02.07.2406L FEMUR REVISION PS SIZE 6 L (K102437) LOT 2108722: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-SET-27. 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-REVISION 02.07.FCL14065 FLUTED EXTENSION STEM Ø14MM / L 065MM (K120790) LOT 2402453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2024. EXPIRATION DATE: 2029-06-02. 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-REVISION 02.07.FCL20065 FLUTED EXTENSION STEM Ø20MM / L 065MM (K120790) LOT 189592A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2024. EXPIRATION DATE: 2029-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN SOLD. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT 2010868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2020. EXPIRATION DATE: 2029-11-29. 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. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY KNEE SURGERY (B)(6) 2025. THE PATIENT'S FIRST REVISION WAS ON (B)(6) 2025 FOR AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025 THE PATIENT CAME IN AGAIN DUE TO INFECTION WITH AN UNKNOWN CAUSE. THE SURGEON REVISED THE GMK-REVISION SYSTEM TO A GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149184 GMK REVISION TOTAL KNEE SYSTEM OFFSET CONNECTOR 5 MM JWH MEDACTA INTERNATIONAL SA 02.07.0005 2010868 07630030815607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention