BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 0 LAT

    MDR report key: 5318713 · Received December 22, 2015

    Report

    Report Number
    3005180920-2015-00349
    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
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THE RADIOGRAPHIC DOCUMENTATION SUPPLIED IS NOT SUFFICIENT TO DRAW A CONCLUSION ON THIS CASE. THE REPORTED ACETABULAR MALALIGNMENT IS BARELY VISIBLE, AND THE REPORTED THIN ACETABULAR WALLS CAN ONLY BE SURMISED. A SIGNIFICANT BONE LOSS IN THE METAPHYSEAL MEDIAL FEMUR IS VERY EVIDENT, BUT THE CAUSE IS UNKNOWN. I BELIEVE THIS IS THE ROOT CAUSE FOR REVISION OF THE STEM, BUT I CANNOT DETERMINE ITS ORIGIN. THE BONE SEEMS TO BE OF RATHER POOR QUALITY, BUT THERE IS NO INFORMATION AS TO THE QUALITY OF BONE AT PRIMARY OPERATION. 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 03 DEC 2015 WE WERE INFORMED THAT THE SURGEON CONFIRMED THE MISALIGNED, THE CUP WAS LEFT IN PLACE DUE TO POOR WALL CETABULUM CONDITION AND ONLY THE LINER, 28 TO 32, WAS CHANGED. STEM REPLACED AS WELL. ON 09 DEC 2015 IT WAS COMMUNICATED THAT THE EXPLANTS WILL NOT BE AVAILABLE. BATCH REVIEW PERFORMED ON 21 DECEMBER 2015: LOT 113757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JANUARY 2012. EXPIRATION DATE: 2016-11-30. 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. VERSAFITCUP CC LIGHT ACETABULAR SHELL Ø 50 CODE 01.26.50MBTL LOT. 122504 (NOT MARKETED IN THE USA): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2012. EXPIRATION DATE: 2017-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION DUE TO LOOSENING OF THE STEM. THE CUP WAS WRONGLY POSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844642 AMISTEM H CEMENTLESS STEM SIZE 0 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 113757

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention