BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE 02.18.TF4.LM TIBIAL TRAY FIX CEMENTED S4 LM

    MDR report key: 16285532 · Received February 2, 2023

    Report

    Report Number
    3005180920-2023-00014
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    December 29, 2023
    Report Date
    February 2, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896750
    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 10-JAN-2023. LOT: 2112106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2021. EXPIRATION DATE: 2026-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON NOTICED FROM THE X-RAYS A TIBIAL PLATEAU FRACTURE THROUGH THE KEEL. THE SURGEON USED A PLATE AND SCREWS TO FIXATE THE PATIENT AND DID NOT REVISE ANY IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377745 MOTO PARTIAL KNEE 02.18.TF4.LM TIBIAL TRAY FIX CEMENTED S4 LM KNEE TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 02.18.TF4.LM 2112106 07630030896750

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention