BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 24162767 · Received January 23, 2026

    Report

    Report Number
    3005180920-2026-00045
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345710802
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 9 JANUARY 2026. GMK-SPHERIKA 02.12.3D02R GMK 3DMETAL TIBIAL TRAY SIZE 2R CEMENTLESS (K221850) LOT 2503524: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2025. EXPIRATION DATE: 10-APR-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. CLINICAL EVALUATION: A REVISION SURGERY WAS PERFORMED APPROXIMATELY FOUR MONTHS AFTER THE PRIMARY TKA IMPLANTATION. THE PATIENT RETURNED FOR EVALUATION COMPLAINING OF JOINT INSTABILITY. THE AVAILABLE POSTOPERATIVE X-RAY IMAGES SHOW SLIGHT UNDERSIZING OF THE TIBIAL TRAY. THIS FINDING MAY BE CONSIDERED AMONG THE CONTRIBUTING FACTORS TO THE SUBSIDENCE OBSERVED ON THE PRE-REVISION RADIOGRAPHIC IMAGES, WITH SUBSEQUENT COMPONENT MOBILIZATION, AS SUGGESTED BY THE PRESENCE OF RADIOLUCENT LINES AROUND THE IMPLANT. THIS CONDITION MAY EXPLAIN THE SYMPTOMS REPORTED BY THE PATIENT. BASED ON THE AVAILABLE INFORMATION, THERE ARE NO ELEMENTS TO SUGGEST A DEFECTIVE OR MALFUNCTIONING DEVICE. ROOT CAUSE:ASEPTIC LOOSENING 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 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AS THE RESULT OF TIBIAL LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY FROM GMK 3D METAL 2R CEMENTLESS TO A GMK CEMENTED S2 AND UPSIZED THE INSERT FROM 12MM TO 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228895 GMK 3D METAL TIBIAL TRAY GMK 3DMETAL TIBIAL TRAY SIZE 2R CEMENTLESS MBH MEDACTA INTERNATIONAL SA 02.12.3D02R 2503524 07630345710802

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention