BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID SMS SOLID STEM LAT SIZE 10

    MDR report key: 13091642 · Received December 28, 2021

    Report

    Report Number
    3005180920-2021-01034
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    December 9, 2021
    Report Date
    December 28, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888823
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2021. LOT 1903493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2019. EXPIRATION DATE: 2024-AUG-18. 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 · 0

    DURING THE PRIMARY HIP SURGERY, THE SURGEON OBSERVED THAT A FEMUR FRACTURE HAD OCCURRED INTRAOPERATIVELY, WHEN IMPLANTING THE STEM, AND THE CAUSE IS UNKNOWN. THE SURGEON USED THE IMPACTOR/INSERTER DEDICATED FOR SMS. THE SURGEON REVISED THE SMS SOLID STEM LAT SIZE 10 WITH A QUADRA-P COLLARED LAT. SIZE 5 AND CABLED THE FRACTURE. THE BONE QUALITY WAS EXCELLENT, TYPE A FEMPUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996445 STEM: SMS SOLID SMS SOLID STEM LAT SIZE 10 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.36.070 1903493 07630030888823

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O