BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 11884150 · Received May 26, 2021

    Report

    Report Number
    3005180920-2021-00414
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06.05.2021: LOT 130617: 40 ITEMS MANUFACTURED AND RELEASED ON 26-APR-2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT REVISION PERFORMED 7.5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN (B)(6) YEAR OLD WOMAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: LOOKING AT THE IMAGE ATTACHED TO THE COMPLAINT IT IS VISIBLE THAT THE WHOLE HA COATING ON THE STEM BODY HAS BEEN CORRECTLY COMPLETELY ABSORBED BY THE PATIENT BONE AS EXPECTED. SOME SCRATCHES AND SIGNS ARE PRESENT ON THE NECK AND TAPER PART PROBABLY DUE TO THE REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED LOOSENING.

    Description of Event or Problem · 1

    7 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED THE STEM DUE TO MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779678 STEM: AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 130670 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention