BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 5690867 · Received June 1, 2016

    Report

    Report Number
    3005180920-2016-00254
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    May 2, 2016
    Report Date
    August 4, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 26 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY REPORTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 09MAY2016 AND INCLUDES: THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS ARE NOT AVAILABLE. ON 13 MAY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM LOOSENING IN CEMENTLESS THA LESS THAN 1 YEAR AFTER PRIMARY. FROM THE RADIOGRAPH, THE STEM LOOKS UNDERSIZED, BUT ONLY ONE PROJECTION IS AVAILABLE: IT IS POSSIBLE THAT, DUE TO A PECULIAR FEMORAL MORPHOLOGY, IT WAS WELL STABILIZED ON THE INVISIBLE PLANE. THERE IS NO REASON TO SUSPECT THAT THE FAILURE WAS DUE TO A DEFECTIVE IMPLANT. THE ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY, BUT IT LOOKS LIKE UNDERSIZING MAY HAVE PLAYED A ROLE. BATCH REVIEW PERFORMED ON 30 MAY 2016. LOT 150848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF HIP PAIN. THE SURGEON DETERMINED THE PATIENT WAS HAVING STEM LOOSENING AND PLANNED A REVISION. X-RAY ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348240 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 150848

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention