BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED LAT STEM SIZE 6

    MDR report key: 17349970 · Received July 19, 2023

    Report

    Report Number
    3005180920-2023-00514
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803840
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2001467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2020. EXPIRATION DATE: 2025-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS 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
    36500 STEM: AMISTEM C CEMENTED LAT STEM SIZE 6 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.106 2001476 07630030803840

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention