BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    MDR report key: 14191934 · Received April 25, 2022

    Report

    Report Number
    3005180920-2022-00302
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    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 5 APRIL 2022. LOT 1810467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-FEB-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL COMPONENT AND THE CAUSE OF THE LOOSE TIBIAL COMPONENT IS UNKNOWN. ABOUT 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128389 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203R 1810467 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention