BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 1 STD

    MDR report key: 6921468 · Received October 6, 2017

    Report

    Report Number
    3005180920-2017-00555
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    October 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: 1,5 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM WAS FOUND TO BE LOOSE AND THEREFORE REVISED. THE REASON OF THE LOOSENING CANNOT BE ESTABLISHED WITH CERTAINTY. THE FEMORAL CANAL IS EXTREMELY NARROW AND THEREFORE STEM IMPLANTATION WAS TECHNICALLY DEMANDING AT RISK; IN FACT, THE STEM APPEARS TO BE PROXIMALLY UNDERSIZED AND SLIGHTLY VARUS, BUT THIS IS PROBABLY DUE TO THE VERY LIMITED DIAPHYSEAL DIMENSION. NO REASON TO ASCRIBE THIS FAILURE TO A FAULTY DEVICE. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 140745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 APRIL 2014. EXPIRATION DATE: 2020-02-29. 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 CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. NO TRAUMA REPORTED. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702272 AMISTEM H, HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 140745 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention