BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED LAT STEM SIZE 3

    MDR report key: 17037703 · Received June 1, 2023

    Report

    Report Number
    3005180920-2023-00396
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 9, 2023
    Report Date
    January 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BACH REVIEW PERFORMED ON 11 MAY 2023: LOT 112383: 46 ITEMS MANUFACTURED AND RELEASED ON 26-JUL-11. EXPIRATION DATE: 2016-JUN-30. 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

    THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. ABOUT 11 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD, STEM, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131404 AMISTEM H, HA COATED LAT STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.143 112383 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention