BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 19097610 · Received April 12, 2024

    Report

    Report Number
    3005180920-2024-00212
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-MAR-2024. LOT 1901366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2019. EXPIRATION DATE: 2024-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL BASEPLATE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793972 GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 1901366 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention