BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22573888 · Received July 23, 2025

    Report

    Report Number
    3005180920-2025-00691
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 JULY 2025 GMK-SPHERE 02.12.0210FL GMK-SPHERE TIBIAL INSERT - FLEX S2L - 10 MM (K121416) LOT. 2429204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-DEC-2024. EXPIRATION DATE: 2029-NOV-14. 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 COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 09 JULY 2025 GMK-SPHERE 02.07.1202L TIBIAL TRAY FIX CEMENTED S.2L (K090988) LOT. 2436402: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MARCH-2025. EXPIRATION DATE: 09-MARCH-2030. 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 02.12.0211FL GMK-SPHERE TIBIAL INSERT - FLEX S2L - 11 MM (K140826) LOT. 2427644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2024. EXPIRATION DATE: 14-OCT-2029. 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. VISUAL INSPECTION AN INTRA-OPERATIVE ISSUE WAS REPORTED INVOLVING THE COUPLING MECHANISM BETWEEN THE TIBIAL BASEPLATE AND INSERT OF A GMK SPHERE IMPLANT. A VISUAL INSPECTION WAS CONDUCTED ON THE RETRIEVED 10 MM AND 11 MM TIBIAL INSERTS ASSOCIATED WITH THE EVENT. BOTH INSERTS EXHIBITED DAMAGE LOCALIZED PRIMARILY IN THE LATERAL POSTERIOR ENGAGEMENT ZONES-AREAS DESIGNED TO INTERFACE WITH THE CORRESPONDING REGIONS OF THE TIBIAL BASEPLATE. THE DAMAGE WAS CHARACTERIZED BY INCISION-LIKE MARKINGS CONSISTENT WITH THE PERIPHERAL GEOMETRY OF THE BASEPLATE, SUGGESTING IMPINGEMENT DURING THE COUPLING PROCESS.IT IS BELIEVED THAT DURING INITIAL INSERTION ATTEMPTS, THE INSERT MAY HAVE BEEN MISALIGNED WITH THE BASEPLATE. THIS MISALIGNMENT LIKELY LED TO LOCALIZED DAMAGE, WHICH IN TURN PREVENTED SECURE FIXATION IN SUBSEQUENT ATTEMPTS.A THIRD INSERT (12 MM) WAS OPENED AND SUCCESSFULLY COUPLED WITH THE BASEPLATE, RESOLVING THE ISSUE.BASED ON VISUAL ASSESSMENT, THERE IS NO INDICATION OF A MANUFACTURING DEFECT OR DEVICE MALFUNCTION.THE ISSUE APPEARS TO BE RELATED TO INTRA-OPERATIVE TECHNIQUE RATHER THAN PRODUCT PERFORMANCE. 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 POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    FAILURE OF COUPLING OF THE 10 MM AND 11 MM INSERTS WITH THE TIBIAL TRAY. A 12[?]MM INSERT WAS FINALLY IMPLANTED. SURGERY WAS PROLONGED BY ABOUT 50 MINUTES. THE SURGERY CONCLUDED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731543 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L JWH MEDACTA INTERNATIONAL SA 02.12.0210FL 2429204 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other