BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24964783 · Received April 23, 2026

    Report

    Report Number
    3005180920-2026-00363
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862649
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 APRIL 2026 GMK-SPHERE 02.12.0511FL GMK-SPHERE TIBIAL INSERT - FLEX S5L: 11 MM (K140826), LOT 1811463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 06-MAR-2024. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND I&D, THEN REVISED THE 11 MM INSERT TO A 14 MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027025 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S5L - 11 MM JWH MEDACTA INTERNATIONAL SA 02.12.0511FL 1811463 07630030862649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention