BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 10349974 · Received July 31, 2020

    Report

    Report Number
    3005180920-2020-00478
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 31, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JULY 2020: LOT 151436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO AN ASEPTIC LOOSENING OF THE FEMORAL STEM. THE SURGEON REVISED THE STEM WITH COMPETITOR DEVICE AND LINER WITH A MEDACTA LINER 4 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813655 STEM: AMISTEM H HA COATED STD STEM SIZE 2 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 151436 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention