BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24882488 · Received April 15, 2026

    Report

    Report Number
    3005180920-2026-00295
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261761
    PMA / PMN Number
    K202022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 MARCH 2026. GMK-SPHERIKA 02.12.E0410FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM (K202022), LOT: 2526543: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2025. EXPIRATION DATE: 2030-10-09. 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. GMK-SPHERIKA 02.12.3D04R GMK 3DMETAL TIBIAL TRAY SIZE 4R CEMENTLESS (K221850), LOT: 2407418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2024. EXPIRATION DATE: 2029-04-25. 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. CLINICAL EVALUATION: DURING A TOTAL KNEE ARTHROPLASTY, THE TIBIAL INSERT COULD NOT BE PROPERLY CLIPPED INTO THE TIBIAL TRAY. THE SURGEON THEREFORE DECIDED TO TRIM THE INSERT USING A SCALPEL IN THE AREAS WHERE IMPINGEMENT WAS PERCEIVED. AFTER THIS MODIFICATION, THE INSERT WAS FINALLY ABLE TO CLIP ONTO THE TRAY. IT SHOULD BE NOTED THAT MEDACTA POLYETHYLENE INSERTS ARE NOT INTENDED TO BE MODIFIED OR TRIMMED, AS DONE IN THIS CASE. THEREFORE, POTENTIAL REPERCUSSIONS CANNOT BE EXCLUDED, SUCH AS INSERT INSTABILITY OR THE PRESENCE OF RESIDUAL POLYETHYLENE PARTICLES RESULTING FROM THE TRIMMING PROCESS. THE ROOT CAUSE OF THE EVENT IS DIFFICULT TO DETERMINE. THE SURGICAL TECHNIQUE CLEARLY DESCRIBES THE STEPS REQUIRED TO ENSURE PROPER CLIPPING, EMPHASIZING THAT THE TIBIAL BASEPLATE MUST BE PERFECTLY CLEAN AND FREE OF ANY DEBRIS. THE PRESENCE OF SMALL PARTICLES OR INTERPOSED MATERIAL BETWEEN THE TRAY AND THE INSERT DURING ASSEMBLY COULD HINDER PROPER ENGAGEMENT AND LEAD TO DIFFICULTIES IN ACHIEVING FIXATION. ROOT CAUSE: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. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    DURING THE PRIMARY RIGHT KNEE SURGERY, THE SURGEON WAS HAVING DIFFICULTY GETTING THE INSERT TO FIT INTO THE TIBIAL TRAY. THE SURGEON ATTEMPTED THE FORCE OF PUSH AND HITTING THE INSERT ONTO THE TRAY, BUT IT WOULD NOT SUCCESSFULLY SEAT. THE SURGEON USED A SCALPEL AND TRIMMED THE POSTERIOR LATERAL EDGE OF THE INSERT AND WAS THEN ABLE TO PUSH IT ONTO THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952977 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0410FR 2526543 07630971261761

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other