BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 8666700 · Received June 4, 2019

    Report

    Report Number
    3005180920-2019-00443
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    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 04 JUN 2019: LOT 093010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2010. EXPIRATION DATE: 2015-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 9 YEARS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462676 STEM: AMISTEM H HA COATED STD STEM SIZE 2 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 093010 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention