BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 18256288 · Received December 4, 2023

    Report

    Report Number
    3005180920-2023-00927
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023. LOT 2000584: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2020. EXPIRATION DATE: 2025-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023. GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R (K121416) LOT 1910668: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 2025-03-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT 1910197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. EXPIRATION DATE: 2024-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539748 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2000584 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention