BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 7

    MDR report key: 9909440 · Received April 1, 2020

    Report

    Report Number
    3005180920-2020-00212
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 MARCH 2020: LOT 151447: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2015. EXPIRATION DATE: 2020-07-11. 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 SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, MORE THAN 4 YEARS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376207 STEM: AMISTEM H HA COATED STD STEM SIZE 7 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.137 151447 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention