BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STD STEM SIZE 2

    MDR report key: 14927428 · Received July 6, 2022

    Report

    Report Number
    3005180920-2022-00521
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804274
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JUNE 2022 LOT 2110050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-09-23. 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

    DURING THE PRIMARY HIP SURGERY, WHEN THE SURGEON WAS IMPLANTING THE STEM, LOOSENING OF THE STEM OCCURRED DUE TO A VERTICAL FRACTURE TO THE CALCAR. THE FRACTURED PART WERE FIXED BY CEMENT, AND THE DIFFERENCE IN LEG LENGTH WAS ADJUSTED BY CHANGING THE SIZE OF THE HEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430039 AMISTEM C CEMENTED STD STEM SIZE 2 HIP CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.152 2110050 07630030804274

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention