BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 10605305 · Received September 30, 2020

    Report

    Report Number
    3005180920-2020-00650
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 30, 2020
    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 · 1

    BATCH REVIEW PERFORMED ON 10 SEPTEMBER 2020: LOT 100867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUNE-2010. EXPIRATION DATE: 2015-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 01-JAN-2016. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 101842. BATCH REVIEW PERFORMED ON 10 SEPTEMBER 2020: LOT 101842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2010. EXPIRATION DATE: 2015-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 60 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 01-JAN-2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE PATELLA AND TIBIAL TRAY. 10 YEARS POST PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, INSERT, AND PATELLA AND ADDED AN EXTENSION STEM AND CONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073830 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 R CEMENTED TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 02.07.1204R 100867 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention