BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23166791 · Received September 29, 2025

    Report

    Report Number
    3005180920-2025-00974
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 22 SEPTEMBER 2025: GMK-REVISION 02.07.0684L REVISION TIBIAL TRAY SIZE 4 LEFT - FINISHING (K123721) LOT 2312233: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2023. EXPIRATION DATE: 2028-10-03. 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 DEVICES ALSO REVISED: BATCH REVIEWS PERFORMED ON 22 SEPTEMBER 2025: GMK-REVISION 02.07.2404L FEMUR REVISION PS CEMENTED S.4L (K102437) LOT 2420356: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2024. EXPIRATION DATE: 2029-08-01. 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 02.07.0003 OFFSET CONNECTOR 3 MM (K102437) LOT 2409213: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2024. EXPIRATION DATE: 2029-04-29. 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 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT 2109450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2021. EXPIRATION DATE: 2026-09-08. 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 02.07.7404FDW FEMORAL DISTAL AUGMENTATION SIZE 4/4MM-TIALV (K210010) LOT 2309031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2023. EXPIRATION DATE: 2028-04-22. 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. TWO DEVICES FROM THIS LOT WERE INVOLVED IN THIS COMPLAINT. GMK-REVISION 02.07.FCL15105 FLUTED EXTENSION STEM Ø15MM / L 105MM (K120790) LOT 2310487: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 2028-08-26. 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.FCL22105 FLUTED EXTENSION STEM Ø22MM / L 105MM (K120790) LOT 161797B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2021. EXPIRATION DATE: 2026-06-10. 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 02.12.E002RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S2 (K202022) LOT 2429345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2024. EXPIRATION DATE: 2029-11-17. 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 02.07.0414SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.4 / 14 MM (K103170) LOT 2243642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2023. EXPIRATION DATE: 2028-01-25. 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. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE DEVICES LISTED IN THIS COMPLAINT WERE ERRONEOUSLY REPORTED BY THE BRANCH AS REVISED WHILE THEY WERE ACTUALLY IMPLANTED. JUST A SPACER WAS REVISED ON THE 10TH OF SEMPTEMBER. CORRECT INFORMATION INVOLVING THE DEVICES USED ON THIS PATIENT HAVE BEEN REPORTED IN MDR 2025-01012 FOLLOWUP. THIS FOLLOWUP IS TO INFORM THAT THE DEVICES LISTED IN THE INITIAL REPORT WERE NOT ACTUALLY REVISED.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SURGERY (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, THE PATIENT HAD PAIN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL THE IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD REVISION COMPONENTS IMPLANTED DURING THE LAST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796736 GMK REVISION TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SEMICONSTRAINED S.4 / 14 MM JWH MEDACTA INTERNATIONAL SA 02.07.0414SCF 2243642

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention