BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM

    MDR report key: 11106976 · Received January 4, 2021

    Report

    Report Number
    3005180920-2021-00003
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896101
    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 18 DECEMBER 2020: LOT 182149: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2018. EXPIRATION DATE: 2023-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(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 1 MONTH AFTER THE PRIMARY SURGERY FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A HEMATOMA HAD DEVELOPED. THE CAUSE OF THE HEMATOMA IS UNKNOWN. THE SURGEON PERFORMED AN WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9451 MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 02.18.IF4.08.RM 182149 07630030896101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention