BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM

    MDR report key: 10127318 · Received June 8, 2020

    Report

    Report Number
    3005180920-2020-00312
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 8, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895890
    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 19 MAY 2020: LOT 172346: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2017. EXPIRATION DATE: 2022-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 9 MONTHS AFTER PRIMARY SURGERY, REPORTING TIGHTNESS OF THE KNEE. THE SURGEON REVISED THE 10MM POLY WITH AN 8MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591961 MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 02.18.IF2.10.LM 172346 07630030895890

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention