BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 15093771 · Received July 25, 2022

    Report

    Report Number
    3005180920-2022-00576
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 28, 2022
    Report Date
    July 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 JULY 2022 LOT 2002831: LOT 2002831: 41 ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2020. EXPIRATION DATE: 2025-06-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTED COMPONENTS: GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT. 2008569.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 1 YEAR FROM PRIMARY FOR CEMENTED TIBIAL TRAY LOOSENING. TIBIAL TRAY AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570515 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.12.T3I4L 2002831 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention