BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM

    MDR report key: 11551136 · Received March 23, 2021

    Report

    Report Number
    3005180920-2021-00228
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818233
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08-MAR-2021: LOT 171352: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2017. EXPIRATION DATE: 2022-APR-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451723 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0510SCF 171352 07630030818233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention