BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22380966 · Received July 2, 2025

    Report

    Report Number
    3005180920-2025-00614
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 4, 2025
    Report Date
    September 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 JUN 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-12-2024. EXPIRATION DATE: 2029-11-25. 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 DEVICES INVOLVED: GMK-SPHERE 02.07.2803L FIXED TIBIAL TRAY SIZE 3 L - TINBN COATING (K202684) LOT. 2340801 BATCH REVIEW PERFORMED ON 06 JUN 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-12-2024. EXPIRATION DATE: 2029-12-09. 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 02.12.0310FL GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM (K121416) LOT. 2432422 BATCH REVIEW PERFORMED ON 06 JUN 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-02-2024. EXPIRATION DATE: 2029-01-22. 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.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER THIS VISUAL INSPECTION IS BASED ON THE ANALYSIS OF THE COMPONENT OBJECT OF THE REPORTED EVENT SENT BACK TO MEDACTA HEADQUARTERS. THE INSERT LOOKS DAMAGED, PARTICULARLY IN THE LATERAL POSTERIOR REGIONS INTENDED TO ENGAGE WITH THE CORRESPONDING SEATING AREAS OF THE TIBIAL BASEPLATE. IT IS BELIEVED THAT DURING THE INITIAL ATTEMPTS TO SEAT THE INSERT INTO THE BASEPLATE, IT MAY NOT HAVE BEEN PROPERLY ALIGNED OR FULLY ENGAGED. THIS MISALIGNMENT LIKELY LED TO DAMAGE OF THE INSERT, WHICH SUBSEQUENTLY PREVENTED SUCCESSFUL FIXATION IN LATER ATTEMPTS. BASED ON THE VISUAL ASSESSMENT, THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT RESULTED FROM A MANUFACTURING DEFECT OR DEVICE MALFUNCTION. THE VERY THIN LAYER OF SENSITIN COATING DOESN'T ALTER THE TOLERANCES OF THE TIBIA INSERT / BASEPLATE COUPLING SYSTEM. ALTHOUGH NO ROOT CAUSE CAN BE CONFIRMED FOR THIS CASE, IT IS MOST LIKELY THAT IN THE FIRST ATTEMPTS TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT WELL POSITIONED AND BECAME DAMAGED, PRECLUDING THE POSSIBILITY TO FIX THE INSERT IN THE FOLLOWING ATTEMPTS. THE INVESTIGATION DOES NOT INDICATE A POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY. DEVICE EVALUATION: D9, H3.

    Description of Event or Problem · 0

    IT WAS NOT POSSIBLE TO COUPLE THE PE INSERT WITH THE TINBN COATED TIBIAL TRAY. BACK-UP INSERT USED, BUT THE SAME PROBLEM OCCURRED. EVENTUALLY, THE SURGEON WAS ABLE TO SEAT THE LINER. DELAY 20-30 MIN (90 MINUTES TOTAL SURGERY)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484794 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 2431658 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other