BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 20117924 · Received September 2, 2024

    Report

    Report Number
    3005180920-2024-00694
    Event Type
    Injury
    Date Received
    September 2, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 AUG 2024: LOT 140012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MARC-2014. EXPIRATION DATE: 2019-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 9 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055680 AMISTEM H HA COATED STD STEM SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 140012 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention