BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24004375 · Received January 8, 2026

    Report

    Report Number
    3005180920-2026-00030
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 8, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 DEC 2025. GMK-SPHERE 02.07.1202R TIBIAL TRAY FIX CEMENTED S.2R (K090988) LOT. 2012636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2021. EXPIRATION DATE: 2026-APR-19. 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-SPHERE 02.12.0023R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+R (K140826) LOT. 2102538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-MAY-02. 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. GMK-SPHERE 02.12.0214CRR GMK SPHERE CR TIBIAL INSERT S2R 14MM (K181635) LOT 185613: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2018. EXPIRATION DATE: 2023-OCT-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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

    AT4 YEARS 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67353 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.2R JWH MEDACTA INTERNATIONAL SA 02.07.1202R 2012636 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention