BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 24738826 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00270
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817298
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 MARCH 2026: GMK-REVISION 02.07.0314SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 MM (K103170) LOT 2346243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2024. EXPIRATION DATE: 2029-JAN-31. 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. SCP14 TINBN COATED SC PEG - 14MM (K210010) LOT 2414028: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2024. EXPIRATION DATE: 2029-JUN-20. 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

    ON (B)(6) 2024, THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY WITH GMK-SPHERE COMPONENTS. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY MDR 2024-00690. ON (B)(6) 2026, THE PATIENT CAME IN REPORTING STIFFNESS AND LACK OF RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY TO GIVE THE PATIENT MORE RANGE OF MOTION. THE SURGERY WAS COMPLETED SUCCESSFULLY MDR2025-00810. ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING LIMITED RANGE OF MOTION WITH A STIFF KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 11MM INSERT TO A 10MM INSERT AND REVISED THE 14MM PEG TO A 10MM PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED - 02.07.0310SCF INSERT SEMICONSTRAINED 10MM S3 2523107 02.07. SCP10 TINBN COATED SC PEG - 10MM 2112334.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802208 GMK REVISION TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 MM JWH MEDACTA INTERNATIONAL SA 02.07.0314SCF 2346243 07630030817298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention