BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4

    MDR report key: 9731550 · Received February 20, 2020

    Report

    Report Number
    3005180920-2020-00070
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803215
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 JANUARY 2020: LOT 1900442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2019. EXPIRATION DATE: 2024-05-07. 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, ONE MONTH AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A FRACTURED FEMUR. THE FRACTURED FEMUR OCCURRED AS A RESULT OF A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196347 STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.13.104L 1900442 07630030803215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention