BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 11077477 · Received December 28, 2020

    Report

    Report Number
    3005180920-2020-00964
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 3, 2020
    Report Date
    December 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    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 28 DECEMBER 2020: LOT 121811: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2012. EXPIRATION DATE: 2018-01. 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 REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS, AND LINER WITH A MEDACTA LINER 8 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539633 STEM: AMISTEM H HA COATED STD STEM SIZE 4 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.134 121811 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention