BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 8MM

    MDR report key: 19328372 · Received May 16, 2024

    Report

    Report Number
    3005180920-2024-00317
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 18, 2024
    Report Date
    May 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895852
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 APRIL 2024. LOT 2112501: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2021. EXPIRATION DATE: 2026-10-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648752 MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 8MM KNEE UNICOMPARTIMENTAL INSERT HSX MEDACTA INTERNATIONAL SA 2112501 07630030895852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention