BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 16495663 · Received March 7, 2023

    Report

    Report Number
    3005180920-2023-00116
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 7, 2023
    Report Date
    March 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2002936: 93 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 91 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER COMPONENT INVOLVED: GMK-SPHERE 02.12.0026L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ L (K140826) LOT. 1909487: 16 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: 2025-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    REVSION SURGERY AT 1 YEAR AND 8 MONTHS FOR CEMENTED FEMUR AND TIBIA LOOSENING. GMK-REVISION IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706219 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205L 2002936 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention