BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23579774 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01105
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 OCT 2025. GMK-SPHERE 02.07.1203L TIBIAL TRAY FIX CEMENTED S.3L (K090988) LOT 2236484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 2027-NOV-27. 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 02.12.0023L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+L (K140826) LOT. 2217027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-SEPT-29. 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 02.12.0310CRL GMK SPHERE CR TIBIAL INSERT S3L 10MM (K181635) LOT. 185581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2018. EXPIRATION DATE: 2023-SEPT-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. 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

    AT2 YEARS 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TRAY, FEMUR AND INSERT TO A GMK-REVISION SYSTEM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862808 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.3L JWH MEDACTA INTERNATIONAL SA 02.07.1203L 2236484 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention