BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23234083 · Received October 7, 2025

    Report

    Report Number
    3005180920-2025-00977
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2025: GMK-REVISION 02.07.0623SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.6 / 23 MM (K103170) LOT. 2246238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28- MARCH-2023. EXPIRATION DATE: 09-MARCH-2028. 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. SCP23 TINBN COATED SC PEG - 23MM (K210010) LOT. 2112339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06- DEC-2021. EXPIRATION DATE: 24-NOV-2026. 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. 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 UNDERWENT REVISION SURGERY ON (B)(6) 2025, CONVERTING FROM NON-MEDACTA TO MEDACTA PRODUCTS. ON (B)(6) 2025, A WASHOUT AND INSERT SWAP FROM GMK-SPHERE TO GMK-REVISION WAS PERFORMED DUE TO AN INFECTION DUE TO UNKNOWN CAUSE. MDR (B)(4). ON (B)(6) 2025, THE PATIENT PRESENTED AGAIN WITH SIGNS OF INFECTION AND UNDERWENT ANOTHER WASHOUT WITH POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746706 GMK REVISION TOTAL KNEE SYSTEM GMK-REVISION FIXED TIBIAL INSERT SEMICONSTRAINED S.6 / 23 MM JWH MEDACTA INTERNATIONAL SA 02.07.0623SCF 2246238

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention