BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 24826095 · Received April 9, 2026

    Report

    Report Number
    3005180920-2026-00294
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 9, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818677
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 MAR 2026. GMK-REVISION 02.07.0520SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 20 MM (K103170) LOT: 187618: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2018. EXPIRATION DATE: 2023-OCT-07. 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. SCP20 TINBN COATED SC PEG - 20MM (K210010) LOT: 2011017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2021. EXPIRATION DATE: 2026-JAN-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE SURGEON REVISED LINER AND PEG HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT 4 YEARS 4 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON OBSERVED THAT THE BONE/TISSUE QUALITY WAS POOR. THE SURGEON REVISED THE SEMICONSTRAINED 20MM S5 INSERT TO A SEMICONSTRAINED 23MM S5 INSERT AND REVISED THE TINBN COATED 20MM PEG TO A TINBN COATED 23MM PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887164 GMK REVISION TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 20 MM JWH MEDACTA INTERNATIONAL SA 02.07.0520SCF 187618 07630030818677

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Required Intervention