BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23107133 · Received September 22, 2025

    Report

    Report Number
    3005180920-2025-00868
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 28 AUGUST 2025: GMK-SPHERE 02.12.E0411FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 11MM (K202022) LOT 2412100: 49 ITEMS MANUFACTURED AND RELEASED ON 02-JULY-2024. EXPIRATION DATE: 2029-06-12. 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-SPHERE 02.12.E002RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S2 (K202022) LOT 2406162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2024. EXPIRATION DATE: 2029-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 113 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 INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    REVISION DUE TO PATIENT PAIN AND INSTABILITY DUE TO A SUBLUXED PATELLA AND THE CAUSE IS UNKNOWN. AT ABOUT 6 MONTHS POST PRIMARY, THE SURGEON UPSIZED THE POLY AND MEDIALIZED THE PATELLA TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655190 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 11MM JWH MEDACTA INTERNATIONAL SA 02.12.E0411FL 2412100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention