BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 2

    MDR report key: 10343413 · Received July 30, 2020

    Report

    Report Number
    3005180920-2020-00454
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2020: LOT 131644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2013. EXPIRATION DATE: 2018-06-30. 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 SINCE 2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: STEM REVISION PERFORMED 6 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES ARE VISIBLE IN GRUEN ZONE 1 AND 2 AND THE STEM LOOKS UNDERSIZED. THE REASON OF THIS CHOICE CANNOT BE ASSESSED ON THE BASIS OF ANTEROPOSTERIOR POSTOPERATIVE RADIOGRAPHIC PROJECTION. 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 PRELIMINARY VISUAL INVESTIGATION SHOWS HEAD WITH SIGNS OF EXTRACTION AS WELL FOR FEMORAL NECK. STEM SHOW RESIDUAL SPOTS OF HA. IT IS NOT POSSIBLE TO DETERMINE AN IMPLANT RELATED FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    6 YEARS AND 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR STEM LOOSENING. STEM AND HEAD REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810567 STEM: AMISTEM H HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.142 131644 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention