BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM

    MDR report key: 10741024 · Received October 27, 2020

    Report

    Report Number
    3005180920-2020-00744
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818295
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 OCTOBER 2020. LOT 120151: (B)(4) MANUFACTURED AND RELEASED ON 15-MAR-2012. EXPIRATION DATE: 2017-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 7 YEARS AND 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207055 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0512FUC 120151 07630030818295

    Patients

    Seq Age Sex Outcome Treatment
    1