BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM

    MDR report key: 14367137 · Received May 12, 2022

    Report

    Report Number
    3005180920-2022-00356
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817410
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 APRIL 2022: LOT 2012971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-MAR-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A COMPETITOR PRIMARY SURGERY AND THEN WAS REVISED WITH MEDACTA COMPONENTS ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON. THE SURGEON PREFORMED A PATELLA TENDON REPAIR AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310491 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0317SCF 2012971 07630030817410

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention