BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 3 LAT

    MDR report key: 5104163 · Received September 25, 2015

    Report

    Report Number
    3005180920-2015-00207
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 27, 2015
    Report Date
    December 22, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 25 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2015: LOT 133082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2013. EXPIRATION DATE: 2018-08-31. 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. DEVICE STILL IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON CALLED MEDACTA ON (B)(6) THE INFORM THAT THE PATIENT HE OPERATED ON THE (B)(6) CALLED HIM AND TOLD HIM THAT SHE HAD A LOT OF PAIN. HE ASKED HER TO COME TO THE HOSPITAL. AFTER THEY TOOK RX, HE SAW THAT THE FEMUR WAS BROKEN. HE REVISED HER IMMEDIATELY. HE JUST HAD TO PUT CERCLAGE CABLES AND THE SAME STEM IS STILL IN PLACE. THEY DON'T KNOW THE REASON OF THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634051 AMISTEM H FEMORAL STEM SIZE 3 LAT FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 133082

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention