BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4

    MDR report key: 18657174 · Received February 7, 2024

    Report

    Report Number
    3005180920-2024-00015
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 8, 2024
    Report Date
    February 7, 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 11-JAN-2024. LOT 130678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792836 STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 HIP STEM LZO MEDACTA INTERNATIONAL SA 130678 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention