BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25148965 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00432
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261518
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 ARPIL 2026 GMK-SPHERIKA 02.12.E0310FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 10MM (K202022) LOT 2431924: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2025. EXPIRATION DATE: 20-JAN-2030. 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. GMK-SPHERIKA 02.12.KA13L GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED (K211004) LOT 2347599: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2024. EXPIRATION DATE: 04-APR-2029. 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-SPHERIKA 02.12.T4I3L GMK-SPHERE TIBIAL COMPONENT CEMENTED T4I3L (K121416) LOT 2242814: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2023. EXPIRATION DATE: 01-FEB-2028. 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 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA COMPONENTS TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376982 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0310FL 2431924 07630971261518

    Patients

    Seq Age Sex Outcome Treatment
    1