BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23854083 · Received December 19, 2025

    Report

    Report Number
    3005180920-2025-01265
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821783
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 DECEMBER 2025. GMK-SPHERE 02.07.2802L FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING (K202684) LOT: 2219071: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 09-JAN-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. CLINICAL AND R& D ANALYSIS. A TOTAL KNEE REVISION SURGERY WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE PRIMARY CEMENTED TOTAL KNEE ARTHROPLASTY DUE TO MOBILIZATION OF THE TIBIAL COMPONENT. PHOTOGRAPHIC DOCUMENTATION OF THE EXPLANTED COMPONENTS SHOWS NO CEMENT REMAINING ON THE TIBIAL BASEPLATE, WHILE RESIDUAL CEMENT WAS OBSERVED ON PORTIONS OF THE FEMORAL COMPONENT. THIS DIFFERENTIAL FINDING MAY INDICATE A LOCALIZED ISSUE AT THE TIBIAL CEMENT-IMPLANT INTERFACE, POTENTIALLY ORIGINATING DURING THE CEMENTATION PHASE AND RESULTING IN INADEQUATE ADHESION. THE CEMENTATION PROCESS CAN BE INFLUENCED BY MULTIPLE FACTORS, INCLUDING IMPLANT AND OPERATING ROOM TEMPERATURE, TIMING OF CEMENT APPLICATION AND COMPONENT INSERTION, PRESENCE OF FLUIDS OR CONTAMINANTS AT THE BONE-CEMENT OR IMPLANT-CEMENT INTERFACE, AND POTENTIAL DEVIATIONS IN CEMENT HANDLING, TRANSPORTATION, OR STORAGE (E.G., TRANSIENT EXPOSURE TO ELEVATED TEMPERATURES), AS WELL AS PROCEDURAL OR ENVIRONMENTAL FACTORS UNRELATED TO THE IMPLANT DESIGN OR MANUFACTURE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS INSUFFICIENT EVIDENCE TO ESTABLISH A DEFINITIVE ROOT CAUSE OR TO ATTRIBUTE THE EVENT TO A FAULTY DEVICE. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. PHOTOGRAPHIC REVIEW OF THE EXPLANTED COMPONENTS SHOWED NO CEMENT ON THE TIBIAL BASEPLATE, SUGGESTING A POTENTIAL LOCALIZED ISSUE DURING THE CEMENTATION PHASE, LIKELY INFLUENCED BY SURGICAL OR ENVIRONMENTAL FACTORS RATHER THAN THE IMPLANT ITSELF. THERE IS NO INDICATION THAT THE DEVICE CONTRIBUTED TO THE EVENT OR THAT ANY MANUFACTURING-RELATED ISSUE OCCURRED.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO TIBIAL TRAY LOOSENING. X-RAYS SHOWED THE PROSTHESIS TO BE CORRECTLY POSITIONED, ALTHOUGH THE PATIENT REPORTED PAIN AND THE BONE SCAN SHOWED INCREASED UPTAKE. DURING REVISION, NO CEMENT TRACES WERE OBSERVED ON THE TIBIAL SIDE, AND ONLY A SMALL RESIDUE WAS FOUND ON THE FEMORAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591238 GMK TOTAL KNEE SYSTEM FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING JWH MEDACTA INTERNATIONAL SA 02.07.2802L 2219071 07630030821783

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention