BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3

    MDR report key: 17190146 · Received June 23, 2023

    Report

    Report Number
    3005180920-2023-00452
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    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 23 JUNE 2023: LOT 1902676: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2019. EXPIRATION DATE: 2024-07-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 23 JUNE 2023: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 1902820: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2019. EXPIRATION DATE: 2024-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944658 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203L 1902676 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention