BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 5 STD

    MDR report key: 6860920 · Received September 13, 2017

    Report

    Report Number
    3005180920-2017-00514
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    August 15, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804564
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 103232: 60 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2010. EXPIRATION DATE: (B)(6) 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ON 02 OCTOBER 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE STEM SHOWED A COATING ALMOST TOTALLY ABSORBED, EXCEPT SOME AREAS IN THE DISTAL PART. BIG GROOVES IN THE LOWER TAPER AND SIGNS ON THE NECK ARE VISIBLE FOR THE EXTRACTION OF THE STEM. THE DM LINER SHOWED A YELLOWED EXTERNAL SURFACE AND SOME SMALL SIGN. THE METAL HEAD DID NOT MOVE WELL, PROBABLY DUE TO THE DEFORMED LINER AFTER WASHING/STERILIZATION OR FOR THIRD BODY BETWEEN THE TWO SURFACES. FROM THE RECEIVED COMPONENTS IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REMOVED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641968 AMISTEM H, HA COATED STEM SIZE 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 103232 07630030804564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention