BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID STEM STD SIZE 10

    MDR report key: 13306974 · Received January 20, 2022

    Report

    Report Number
    3005180920-2022-00026
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    December 21, 2021
    Report Date
    January 20, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888694
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2021. LOT 2100579: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND A FRACTURED FEMUR. THE SURGEON REVISED THE HEAD AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849233 STEM: SMS SOLID STEM STD SIZE 10 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.36.050 2100579 07630030888694

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention