BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2

    MDR report key: 9799437 · Received March 6, 2020

    Report

    Report Number
    3005180920-2020-00134
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720014
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2020: LOT 1904135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2019. EXPIRATION DATE: 2024-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEW DAYS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. BASED ON THE IMAGE RECEIVED, IT IS NOT POSSIBLE TO DETERMINE AN IMPLANT RELATED FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ONE WEEK AFTER THE PRIMARY SURGERY, DUE TO FEMORAL FRACTURE. THE SURGEON DECIDED TO USE A STAPPING TO CONTAIN THE FRACTURE, NO IMPLANT REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON FOR THE FRACTURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265297 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1904135 07630040720014

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention