BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID STEM LAT SIZE 7

    MDR report key: 11229071 · Received January 26, 2021

    Report

    Report Number
    3005180920-2021-00074
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888793
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05.JAN.2021: LOT 1903491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2019. EXPIRATION DATE: 2024-08-20. 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

    REVISION SURGERY PERFORMED 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM SUBSIDENCE. THE SURGEON REVISED THE STEM AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126859 STEM: SMS SOLID STEM LAT SIZE 7 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.36.067 1903491 07630030888793

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention