BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 5597393 · Received April 22, 2016

    Report

    Report Number
    3005180920-2016-00180
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 24, 2016
    Report Date
    July 22, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 22 JULY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE (B)(6) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEMORAL STEM LOOSENING AT 3 YEARS IN UNCEMENTED THA. DIFFUSED RADIOLUCENCIES LEAD TO THINK THAT MOBILIZATION WAS PROGRESSIVE BUT CAUSES CANNOT BE DETERMINED. ACCORDING TO REPORT, AS IT WAS TO BE EXPECTED, THE STEM WAS EASY TO REMOVE AND THIS SHOWS LACK OF OSSEOINTEGRATION. NO REPORTS ON PATIENT ALLERGY OR SUSPECTED INFECTIONS. NO REASON TO THINK THAT THE DEVICE WAS FAULTY. BATCH REVIEW PERFORMED ON 20 APRIL 2016. LOT 130048: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    MOBILIZATION OF THE STEM. REVISION SURGERY SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253906 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 130048

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention