BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM

    MDR report key: 11444819 · Received March 9, 2021

    Report

    Report Number
    3005180920-2021-00193
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 182203: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2018. EXPIRATION DATE: 2023-06-13. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340131 MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 182203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention