BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHER TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 17161710 · Received June 20, 2023

    Report

    Report Number
    3005180920-2023-00440
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 26, 2023
    Report Date
    June 20, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 MAY 2023: LOT 2011074: 131 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 124 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR CEMENTED TIBIAL TRAY LOOSENING, CAUSING KNEE INSTABILITY, 1 YEAR AND 8 MONTHS POST PRIMARY. TIBIAL TRAY AND LINER WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015007 GMK-SPHER TIBIAL TRAY FIXED CEMENTED SIZE 2 L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2011074 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention