BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 13891609 · Received March 24, 2022

    Report

    Report Number
    3005180920-2022-00194
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    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 23 FEBRUARY 2022. LOT 2002931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JULY-2020. EXPIRATION DATE: 2025-JULY-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. REVISION SURGERY ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY DUE TO MALPOSITIONING OF THE TIBIAL COMPONENT. FROM VISUAL INVESTIGATION ON THE RETURNED EXPLANTED COMPONENTS, NO RESIDUAL CEMENT CAN BE OBSERVED ON THE DISTAL SURFACE OF THE TIBIAL BASEPLATE. ON THE ARTICULAR SURFACES OF THE TIBIAL INSERT, NO SIGNS OF WEAR OR DELAMINATION CAN BE NOTED. 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). THE ABSENCE OF CEMENT IS NOT EVIDENCE OF A FAULTY DEVICE. FROM VISUAL INSPECTION, THERE IS NO EVIDENCE TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY DUE TO MALPOSITIONING OF THE TIBIAL COMPONENT. THE SURGEON EXPLANTED THE TIBIAL COMPONENT THAT WAS COMPLETELY LOOSE WITHOUT ANY CEMENT ON THE BACK SURFACE. THE SURGEON (PRIMARY SURGERY) COMMENTED THAT THE ISSUE WAS DUE TO THE SUBOPTIMAL POSITION OF THE DEVICE DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880436 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2002931 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention