BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24321111 · Received February 12, 2026

    Report

    Report Number
    3005180920-2026-00074
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 JAN 2026. LOT 2203355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2022. EXPIRATION DATE: 2027-JUN-13. 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: 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

    AT 3 YEARS 2 MONTHS, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL COMPONENT TO A GMK-REVISION COMPONENT AND REVISED THE INSERT FROM AN 11MM TO A 14MM SIZING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386551 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L JWH MEDACTA INTERNATIONAL SA 02.12.T3I4L 2203355 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention