BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 24343890 · Received February 16, 2026

    Report

    Report Number
    3005180920-2026-00099
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345710833
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2026. GMK-SPHERIKA 02.12.3D04L GMK 3DMETAL TIBIAL TRAY SIZE 4L CEMENTLESS (K221850) LOT: 2435208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2025. EXPIRATION DATE: 26-FEB-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. E0410FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 10MM (K202022) LOT: 2421779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2024. EXPIRATION DATE: 12-SEP-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 PATIENT DETAILS. CLINICAL EVALUATION. A REVISION SURGERY WAS PERFORMED APPROXIMATELY FIVE MONTHS AFTER PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) DUE TO MOBILIZATION OF THE TIBIAL COMPONENT. THE AVAILABLE X-RAY IMAGING CONFIRMS LOOSENING OF THE TIBIAL COMPONENT, RADIOGRAPHICALLY EVIDENCED BY A SLIGHT ELEVATION OF ITS LATERAL ASPECT FROM THE UNDERLYING BONE, RESULTING IN A MEDIAL TILT OF THE COMPONENT. AS A CONSEQUENCE, THE KNEE APPEARED CLINICALLY UNSTABLE UPON EXAMINATION. ASEPTIC LOOSENING IS A KNOWN AND LITERATURE-REPORTED ADVERSE EVENT FOLLOWING PRIMARY TKA, AND ITS ETIOLOGY IS OFTEN MULTIFACTORIAL AND NOT ALWAYS CLEARLY IDENTIFIABLE. CONSIDERING THE RELATIVELY SHORT TIME ELAPSED SINCE THE PRIMARY SURGERY, IT IS POSSIBLE THAT ADEQUATE BONE INTEGRATION DID NOT OCCUR SUCCESSFULLY IN THIS CASE. HOWEVER, BASED ON THE AVAILABLE CLINICAL AND RADIOLOGICAL INFORMATION, THE ROOT CAUSE OF THE FAILURE CANNOT BE DEFINITIVELY DETERMINED. THERE IS NO EVIDENCE TO SUGGEST A DEFECT OR MALFUNCTION OF THE IMPLANTED PROSTHETIC COMPONENT. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. ASEPTIC LOOSENING IS A KNOWN AND LITERATURE-REPORTED ADVERSE EVENT FOLLOWING PRIMARY TKA, AND ITS ETIOLOGY IS OFTEN MULTIFACTORIAL AND NOT ALWAYS CLEARLY IDENTIFIABLE. CONSIDERING THE RELATIVELY SHORT TIME ELAPSED SINCE THE PRIMARY SURGERY, IT IS POSSIBLE THAT ADEQUATE BONE INTEGRATION DID NOT OCCUR SUCCESSFULLY IN THIS CASE. HOWEVER, BASED ON THE AVAILABLE CLINICAL AND RADIOLOGICAL INFORMATION, THERE IS EVIDENCE OF A SLIGHT ELEVATION OF THE LATERAL ASPECT OF THE TIBIAL COMPONENT FROM THE UNDERLYING BONE, RESULTING IN A MEDIAL TILT OF THE COMPONENT. CONSEQUENTLY, THE KNEE APPEARED CLINICALLY UNSTABLE UPON EXAMINATION. THE ROOT CAUSE OF THE FAILURE CANNOT BE DEFINITIVELY DETERMINED. 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, DURING APOST-OPERATIVEAPPOINTMENTIT WAS OBSERVED THAT THE LEFT KNEE COMPONENTS HAD SHIFTED DUE TO LOOSENING OF THE TIBIAL TRAY. THE SURGEON CONFIRMED THE KNEE WAS NO LONGER BALANCED AND STABILITY WAS COMPROMISED. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE REVISED FROM A CEMENTLESS TO A CEMENTED SYSTEM, AND THE LINER WAS UPSIZED (FROM 10 MM TO 13 MM) TO IMPROVE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186792 GMK 3D METAL TIBIAL TRAY GMK 3DMETAL TIBIAL TRAY SIZE 4L CEMENTLESS MBH MEDACTA INTERNATIONAL SA 02.12.3D04L 2435208 07630345710833

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention