BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERIKA CEMENTLESS

    MDR report key: 23886583 · Received December 24, 2025

    Report

    Report Number
    3005180920-2025-01316
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 16, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345799395
    PMA / PMN Number
    K223548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2025. GMK-SPHERIKA 02.12.KA176R GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S6+R (K223548) LOT 2425406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2025. EXPIRATION DATE: 09-JAN-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. GMK-SPHERIKA 02.12.E0610FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6R - 10MM (K202022) LOT 2337149: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2023. EXPIRATION DATE: 26-SEP-2028. 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 02.12.3D06R GMK 3DMETAL TIBIAL TRAY SIZE 6R (K221850) LOT 2339135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JAN-2024. EXPIRATION DATE: 08-JAN-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:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 WEEK FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, POLY AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058893 GMK SPHERIKA CEMENTLESS GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S6+R MBH MEDACTA INTERNATIONAL SA 02.12.KA176R 2425406 07630345799395

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention