BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM

    MDR report key: 9932413 · Received April 7, 2020

    Report

    Report Number
    3005180920-2020-00231
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 12, 2020
    Report Date
    April 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 24 MARCH 2020: LOT 132304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2013. EXPIRATION DATE: 2018-06-30. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 5 YEARS AND 4 MONTHS AFTER THE PRIMARY REPORTING INSTABILITY DUE TO THE SOFT TISSUES IN THE KNEE LOOSENING UP OVER TIME. THE SURGEON REVISED THE MEDACTA TIBIAL INSERT POSTERO STABILIZED FIXED SIZE 4/10 MM WITH A MEDACTA INSERT POSTERO STABILIZED FIXED SIZE 4/17 MM TO PROVIDE MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395832 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 132304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention