BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 3 LAT

    MDR report key: 5318738 · Received December 22, 2015

    Report

    Report Number
    3005180920-2015-00352
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    December 2, 2015
    Report Date
    March 29, 2016
    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

    THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: INTRAOPERATIVE FEMORAL FRACTURE OCCURRING IN AN ELDERLY PATIENT. IT IS NOT CLEAR WHEN THE FRACTURE HAS BEEN NOTICED; MOST PROBABLY IT HAPPENED DURING FEMORAL PREPARATION OR IMPLANTATION OF FINAL STEM AND WENT UNNOTICED. RE-OPERATION WAS NECESSARY TO IMPLANT A LONGER STEM AND CERCLAGE. THE ROOT CAUSE CANNOT BE DETERMINED WITH PRECISION. INTRAOPERATIVE FRACTURES ARE A KNOWN POSSIBLE COMPLICATION OF THA OPERATIONS. THERE IS NO SPECIFIC REASON TO SUSPECT THAT THIS CASE WAS ORIGINATED BY A PROBLEM OF THE DEVICES. ON 01 MARCH 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON 02 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 IT WAS COMMUNICATED THAT THE EXPLANT IS NOT AVAILABLE. BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 150142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION (THE SAME DAY OF PRIMARY SURGERY) DUE TO BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844641 AMISTEM H CEMENTLESS STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 150142

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention