BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23615334 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01171
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    November 4, 2025
    Report Date
    February 17, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826818
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 FEBRUARY 2026. GMK-SPHERE 02.12.0514FL GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM (K121416) LOT 1910178: 25 ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. EXPIRATION DATE: 15-DEC-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0510FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 10 MM (K121416) LOT 2244444: 50 ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2023. EXPIRATION DATE: 17-JAN-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 43 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 NOVEMBER 2025. GMK-SPHERE 02.12.0514FL GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM (K121416) LOT 1910178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. EXPIRATION DATE: 15-DEC-2024. 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. ROOT CAUSE: 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 DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT REPORTS KNEE PAIN DUE TO SWELLING AND LAXITY, PROBABLY RELATED TO STRENUOUS EXERCISE ACTIVITY. IT WAS A BILATERAL INSTABILITY, SO THE SURGEON REVISED THE INSERTS IN BOTH KNEES (LEFT KNEE FROM 14 MM TO 16 MM; RIGHT KNEE FROM 10 MM TO 11 MM AND SCAR TISSUE REMOVAL). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT REPORTS KNEE PAIN DUE TO SWELLING AND LAXITY, PROBABLY RELATED TO STRENUOUS EXERCISE ACTIVITY. A 14 MM TIBIAL INSERT IS CURRENTLY IN PLACE, AND THE SURGEON INTENDS TO REPLACE IT. THEREFORE, THE SURGEON HAS REQUESTED 15 MM AND 16 MM INSERTS FOR ASSESSMENT, IN ORDER TO DETERMINE WHICH ONE WOULD BE MOST SUITABLE FOR THE PATIENT. THE SURGEON REQUESTED THE 15 MM AND 16 MM SIZES BECAUSE HE DID NOT BELIEVE THAT A STANDARD SIZE INCREASE (17 MM) WOULD BE FEASIBLE. X-RAYS FROM APRIL 2025 DEMOSTRATEDWELL-POSITIONED KINEMATICTKR WITH CENTRALLY TRACKING PATELLA (THE PATELLA WAS NOT REPLACED).A MILD EFFUSION WAS OBSERVED IN THE LEFT KNEE WITHOUT SIGNS OF INFECTION, AS WELL AS A SLIGHT ANTERIOR DRAWER LAXITY WITH THE KNEE IN 90 DEGREES OF FLEXION. NO LOOSENING OF THE COMPONENTS WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024003 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S5L - 14 MM JWH MEDACTA INTERNATIONAL SA 02.12.0514FL 1910178 07630030826818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other