BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 9MM

    MDR report key: 15680274 · Received October 27, 2022

    Report

    Report Number
    3005180920-2022-00828
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    October 14, 2022
    Report Date
    October 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896002
    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 17 OCTOBER 2022: LOT 2201830: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2022. EXPIRATION DATE: 2027-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF AFTER PRIMARY 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
    2599086 MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 9MM UNICOMPARTIMENTAL KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 02.18.IF3.09.RM 2201830 07630030896002

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention