BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COATED STD STEM SIZE 1

    MDR report key: 10566034 · Received September 22, 2020

    Report

    Report Number
    3005180920-2020-00633
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2020: LOT 153417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2015. EXPIRATION DATE: 2020-09-13. 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, 4 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030355 AMISTEM H COATED STD STEM SIZE 1 HIP UNCEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 153417 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention