BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERETIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 18451505 · Received January 5, 2024

    Report

    Report Number
    3005180920-2023-01051
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 DECEMBER 2023. LOT 1907840: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 14 DECEMBER 2023. GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R () LOT 1910668: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 2025-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY MEDACTA R&D KNEE PROJECT MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 3 YEAR AND 2 MOTHS FROM PRIMARY DUE TO TIBIA AND FEMORAL LOOSENING. FROM VISUAL INSPECTION OF THE REMOVED COMPONENTS SENT BASK FOR INVESTIGATION, NO RESIDUAL CEMENT CAN BE NOTED ON THE DISTAL SURFACE OF TIBIAL BASEPLATE AND ON THE INTERNAL SURFACES OF THE FEMORAL COMPONENT. SOME HALOS IS ALSO NOTICEABLE, MOST LIKELY DUE TO THE WASHING PROCESS. THE ARTICULAR SURFACES OF THE TIBIAL INSERT PRESENT SOME DENTS AND SMALL CRATERS, LIKE IF A THIRD BODY (LIKE CEMENT) WAS INTERPOSED. ARTICULAR SURFACES OF THE FEMORAL COMPONENT IS NOT DAMAGED. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT CAN BE RELATED TO MULTIPLE FACTORS, MOST LIKELY NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, TIME, PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE). ABSENCE OF CEMENT, IS NOT AN EVIDENCE OF A FAULTY DEVICE. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 3 YEARS AFTER PRIMARY CEMENTED TKA, BOTH COMPONENTS GET LOOSE AND NEED REPLACEMENT. ACCORDING TO RADIOGRAPHS AND PICTURES, A CEMENTATION PROBLEM CAN BE SUSPECTED: THE METAL PARTS APPEAR TO BE DETACHED FROM CEMENT, AND NO RESIDUAL CEMENT WAS VISIBLE ON EITHER EXPLANTED COMPONENT. THIS TYPE OF PHENOMENON MAY HAPPEN WHEN, FOR INSTANCE, CEMENT APPLICATION IS DELAYED, BUT OF COURSE WE CANNOT STATE THAT THIS IS THE ASCERTAINED CAUSE OF THIS CASE. HOWEVER, WE SEE NO REASON TO SUSPECT A FAULTY IMPLANT.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 2 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIAL AND FEMORAL COMPONENTS LOOSENING. DURING THE SURGERY, IT WAS OBSERVED THAT THERE WAS NO CEMENT ON BOTH COMPONENTS AND THE LINER SEEMS TO BE DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434790 GMK-SPHERETIBIAL TRAY FIXED CEMENTED SIZE 4 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 1907840 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention