BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 10264553 · Received July 13, 2020

    Report

    Report Number
    3005180920-2020-00410
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JUNE 2020: LOT 152801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2016.

    Description of Event or Problem · 1

    1 YEAR AND 9 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729346 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 02.07.1202R 152801 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention