BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24429833 · Received February 24, 2026

    Report

    Report Number
    3005180920-2026-00114
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 24, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261365
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JANUARY 2026. GMK-SPHERIKA 02.12. E0212FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 12MM (K202022) LOT: 2427169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2024. EXPIRATION DATE: 09-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. GMK-SPHERIKA 02.12. KA12R GMK SPHERIKA FEMORAL COMPONENT S2+R CEMENTED (K211004) LOT: 2400546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2024. EXPIRATION DATE: 12-MAY-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. ROOT CAUSE: IMPLANT DISLOCATION IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION BETWEEN THE CEMENTED FEMORAL COMPONENT AND TIBIAL INSERT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR FROM GMK-SPHERIKA TO A GMK-REVISION AND THE INSERT (FROM 12MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628783 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 12MM JWH MEDACTA INTERNATIONAL SA 02.12.E0212FR 2427169 07630971261365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention