BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2

    MDR report key: 19329133 · Received May 16, 2024

    Report

    Report Number
    3005180920-2024-00307
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    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 23-APR-2024. LOT 160734: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2016. EXPIRATION DATE: 2021-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619033 STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2 HIP COATED STD STEM LZO MEDACTA INTERNATIONAL SA 160734 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention