BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22529149 · Received July 17, 2025

    Report

    Report Number
    3005180920-2025-00676
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261679
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-07-2025 GMK-SPHERIKA 02.12. E0314FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 14MM (K202022) LOT. 2409134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-05-2024 EXPIRATION DATE: 2029-04-19. 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. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: GMK-SPHERIKA 02.12. KA03L GMK SPHERIKA FEMORAL COMPONENT S3L CEMENTED (K211004) LOT. 2422098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-11-2024 EXPIRATION DATE: 2029-10-15. 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. 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 ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LATERAL DISLOCATION. THE SURGEON REVISED TO A THICKER POLY, 14MM TO 20MM, AND USED SUTURES TO TIGHTEN THE LCL. THE SURGERY WAS COMPLETED SUCCESSFULLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808514 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 14MM JWH MEDACTA INTERNATIONAL SA 02.12.E0314FL 2409134 07630971261679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention