BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22585411 · Received July 24, 2025

    Report

    Report Number
    3005180920-2025-00694
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826177
    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 09 JUL 2025 LOT 2423907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2024. EXPIRATION DATE: 2029-09-15. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.07.1202L TIBIAL TRAY FIX CEMENTED S.2L (K090988) LOT 2432779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2025. EXPIRATION DATE: 2030-01-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ALTHOUGH IT CANNOT BE CONFIRMED, THE ISSUE MAY HAVE RESULTED FROM UNIQUE CONDITIONS OF THE SPECIFIC SURGICAL APPLICATION, PARTICULARLY INVOLVING THE INSERT NOT BEING WELL ALIGNED DURING THE FIRST CLIPPING ATTEMPT, RESULTING IN DAMAGE WHICH PREVENTED SUBSEQUENT ATTEMPTS. THERE IS NO INDICATION OF A SYSTEMIC DEFICIENCY.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER INTRA-OPERATIVE ISSUE INVOLVING THE COUPLING SYSTEM BETWEEN THE BASEPLATE AND UHMWPE TIBIAL INSERT OF A GMK SPHERE IMPLANT. THIS VISUAL INSPECTION IS BASED ON THE ANALYSIS OF THE COMPONENT OBJECT OF THE REPORTED EVENT SENT BACK TO MEDACTA HEADQUARTER. 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. DEVICE EVALUATION: D9, H3. CORRECTION: D1.

    Description of Event or Problem · 0

    AFTER CEMENTING THE TIBIAL TRAY AND FEMORAL COMPONENT TO THE BONE AND THOROUGHLY IRRIGATING THE SITE, THE SURGEON ATTEMPTED TO MANUALLY ENGAGE THE INSERT MULTIPLE TIMES BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE SURGEON CONFIRMED THERE WERE NO FOREIGN MATERIALS ON THE TIBIAL TRAY AND CLEANED IT AGAIN. SINCE MANUAL INSERTION WAS NOT SUCCESSFUL, THE SURGEON USED AN IMPACTOR (REF. 02.07.4721), BUT THE INSERT STILL DID NOT ENGAGE PROPERLY. A SAME SIZE INSERT (REF. 02.12.0212FL, LOT 2340847) WAS IMPLANTED, AND THE SURGERY COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 1.5 HOURS, AND THE DELAY TIME WAS 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774405 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE 02.12.0212FL GMK-SPHERE TIBIAL INSERT - FLEX S2L - 12 MM JWH MEDACTA INTERNATIONAL SA 02.12.0212FL 2423907 07630030826177

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other