BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM 5 STD

    MDR report key: 6240344 · Received January 11, 2017

    Report

    Report Number
    3005180920-2016-00720
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    January 11, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016 AND INCLUDES: THE STEM WAS REVISED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. ON 04 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: POSTOPERATIVE FEMORAL FRACTURE OCCURRED FEW WEEKS AFTER PRIMARY CEMENTLESS THA IN AN OVERWEIGHT (B)(6) YEAR OLD PATIENT. THIS EVENT MAY BE THE CONSEQUENCE OF THE INTRAOPERATIVE BONE WEAKENING, A NORMAL SIDE EFFECT OF FEMORAL PREPARATION. IN THIS CASE THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON 09 JANUARY 2017. LOT 160751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAY 2016. EXPIRATION DATE: 2021-05-03. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    PERIPROSTHETIC FRACTURE POSTOPERATIVE. THE SURGEON PLANNED TO PERFORM A CERCLAGE OR TO CHANGE THE STEM TO A CEMENTED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25218 AMISTEM H, HA COATED STEM 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 160751

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention