BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 LAT

    MDR report key: 6485184 · Received April 12, 2017

    Report

    Report Number
    3005180920-2017-00174
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    March 14, 2017
    Report Date
    April 12, 2017
    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

    BATCH REVIEW PERFORMED ON 10 APRIL 2017. LOT 130063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Description of Event or Problem · 1

    DURING SURGERY AFTER THE STEM HAD BEEN IMPLANTED, THE FEMUR FRACTURED. THE SURGEON CONFIRMED THE PATIENT HAD POOR BONE QUALITY. THE SURGEON CABLED THE FEMUR DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266893 AMISTEM H, HA COATED STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 130063

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention