BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24871670 · Received April 14, 2026

    Report

    Report Number
    3005180920-2026-00306
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262041
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MARCH 2026. GMK-SPHERE 02.12. E0511FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM (K202022) LOT 2428515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2024. EXPIRATION DATE: 24-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-SPHERE 02.12. E003RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S3 (K202022) LOT 2513566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2025. EXPIRATION DATE: 11-JUN-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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED REGARDING THE PATELLA IMPLANT DISLOCATION. THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATING PATELLA AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE FEMORAL COMPONENT, THE TIBIAL TRAY, THE INSERT (FROM 11MM TO A SEMICONSTRAINED 14MM) AND THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933254 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM JWH MEDACTA INTERNATIONAL SA 02.12.E0511FR 2428515 07630971262041

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention