BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/17MM

    MDR report key: 18788786 · Received February 27, 2024

    Report

    Report Number
    3005180920-2024-00064
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818578
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05-FEB-2024. LOT 2003173: (B)(4) MANUFACTURED AND RELEASED ON 24-APR-2020. EXPIRATION DATE: 2025-04-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A COMPETITOR PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102869 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/17MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2003173 07630030818578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention