BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 10611618 · Received October 1, 2020

    Report

    Report Number
    3005180920-2020-00674
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 181930: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-GIU-2018. EXPIRATION DATE: 2023-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 83 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY ANOTHER SIMILAR REPORTED EVENT ON THE SAME LOT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL COMPONENT. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT AND ADDED EXTENSION STEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077731 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1204L 181930 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention