BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5

    MDR report key: 15444795 · Received September 19, 2022

    Report

    Report Number
    3005180920-2022-00715
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803239
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-SEP-2022: LOT 1902975: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM WHERE DURING THE REVISION SURGERY AN OSTEOTOMY OF THE FEMUR TO REMOVE THE STEM WAS NECESSARY. THE SURGEON USED CABLES AND REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR. THE SURGEON REVISED THE STEM WITH A COMPETITOR STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521780 MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.13.105L 1902975 07630030803239

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention