BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/12MM

    MDR report key: 10216608 · Received July 1, 2020

    Report

    Report Number
    3005180920-2020-00373
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816581
    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 REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 143607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2014. EXPIRATION DATE: 2019-08-30. 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 4 YEARS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681914 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/12MM KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.0212PSF 143607 07630030816581

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention