BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P LAT STEM SIZE 6

    MDR report key: 18354868 · Received December 19, 2023

    Report

    Report Number
    3005180920-2023-00976
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720151
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2023: LOT 2111619: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2021. EXPIRATION DATE: 2026-NOV-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA CLINICAL MANAGER: REVISION ABOUT 1 YEAR AND 5 MONTHS AFTER THE INDEX SURGERY DUE TO IMPLANT MOBILIZATION. THE PATIENT REPORTED PAIN. FROM THE RADIOGRAPHIC IMAGES IT IS VISIBLE THE IMPLANT MOBILIZED. WITH THE INFORMATION AT HAND IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT. HOWEVER, THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    ABOUT 1 YEAR AND 5 MONTHS, THE PATIENT WAS REPORTING PAIN AND A REVISION SURGERY WAS PERFORMED DUE TO STEM MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472939 AMISTEM-P LAT STEM SIZE 6 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2111619 07630040720151

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention