BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE CEMENTLESS

    MDR report key: 25268616 · Received May 25, 2026

    Report

    Report Number
    3005180920-2026-00499
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 25, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345799128
    PMA / PMN Number
    K223548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MAY 2026 GMK-SPHERE 02.12.1506R GMK SPHERE FEMUR POROUS TIGROWTHC+HA S6R (K223548) LOT. 2245878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2023. EXPIRATION DATE: 2028-MAY-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.3D05R GMK 3DMETAL TIBIAL TRAY SIZE 5R (K221850) LOT. 2238284: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2022. EXPIRATION DATE: 2027-NOV-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY 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

    REVISION SURGERY DUE TO FEMURAL AND TIBIAL COMPONENTS LOOSENING AT 2 YEARS AND 8 MONTHS. THE SURGEON REVISED ALL GMK-SPHERE IMPLANTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) AND REVISED TO GMK-REVISION IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213742 GMK SPHERE CEMENTLESS GMK SPHERE FEMUR POROUS TIGROWTHC+HA S6R MBH MEDACTA INTERNATIONAL SA 02.12.1506R 2245878 07630345799128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention