BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 9626949 · Received January 24, 2020

    Report

    Report Number
    3005180920-2020-00007
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 24, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    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 02 JANUARY 2020. LOT 133950: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2013. EXPIRATION DATE: 2018-09-30. 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. CLINICAL EVALUATION: FEMORAL COMPONENT (STEM AND HEAD) REVISION PERFORMED 6 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN OF PAIN DUE TO A POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD ALMOST 5 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91582 STEM: AMISTEM H HA COATED STD STEM SIZE 2 HIP STEM COATED CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.132 133950 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention