BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 17348643 · Received July 19, 2023

    Report

    Report Number
    3005180920-2023-00513
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    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 21 JUNE 2023. LOT 2009487: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2020. EXPIRATION DATE: 2025-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 21 JUNE 2023 ON GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R (K121416) LOT. 2012734 LOT 2012734: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND FEMUR 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
    37406 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1204R 2009487 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention