BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22920623 · Received August 29, 2025

    Report

    Report Number
    3005180920-2025-00794
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 AUGUST 2025. GMK-SPHERE 02.07. CXS25 CENTRED 3DMETAL TIBIAL CONE XS H25 (K170149) LOT: 2347248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2024. EXPIRATION DATE: 01-FEB-2029. NO ANOMALIES WERE 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 02.12.0024R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4+R (K140826) LOT: 2400415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2024. EXPIRATION DATE: 17-MAR-2029. NO ANOMALIES WERE 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. E0411FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 11MM (K202022) LOT: 2412103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JULY-2024. EXPIRATION DATE: 12-JUNE-2029. NO ANOMALIES WERE 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.T3I4R GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4R (K121416) LOT: 2407646: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2024. EXPIRATION DATE: 19-JULY-2029. NO ANOMALIES WERE 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. 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. ALTHOUGH A PRECISE ROOT CAUSE CANNOT BE ESTABLISHED, THE INSTABILITY COULD BE ATTRIBUTED TO MALPOSITIONING DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 0

    ALMOST SEVEN MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN RELATED TO VALGUS KNEE INSTABILITY, ATTRIBUTED BY THE SURGEON TO MALPOSITIONING DURING THE PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, TIBIAL TRAY, AND TIBIAL CONE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164085 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4+R JWH MEDACTA INTERNATIONAL SA 02.12.0024R 2400415 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention