BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 7 STD

    MDR report key: 5252444 · Received November 26, 2015

    Report

    Report Number
    3005180920-2015-00291
    Event Type
    Injury
    Date Received
    November 26, 2015
    Date of Event
    October 27, 2015
    Report Date
    February 24, 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 25 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 06 2015 IT WAS COMMUNICATED THAT THE IMPLANTS ARE NOT AVAILABLE FOR INVESTIGATION. ON NOVEMBER 10 2015 WE RECEIVED THE XRAYS FOR THIS CASE. CUP INVOLVED: VERSAFITCUP CC TRIO Ø 62 (K103352) - CODE 01.26.45.0062 LOT UNKNOWN AND NOT AVAILABLE. ON 25 NOVEMBER 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: PATIENT WITH A VERY NARROW PELVIS AND SHALLOW ACETABULUM. THE FIRST CUP COULD NOT BE IMPLANTED IN THE IDEAL POSITION AND ALLOW FOR PROPER RANGE OF MOTION, THIS CONDITION HAS MOST LIKELY ORIGINATED STEM MOBILIZATION. THE CUP IS SHOWN WITH A DEFECT IN ANTEVERSION (HAVING ONLY ONE PROJECTION WE CANNOT SAY IF IT WAS TOO ANTEVERTED OR TOO RETROVERTED). ROOT CAUSE IS MOST PROBABLY CUP POSITIONING, LIKELY DUE TO DIFFICULT PATIENT ANATOMY. BATCH REVIEW PERFORMED ON 26 NOVEMBER 2015: LOT 124058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 DECEMBER 2012. EXPIRATION DATE: 2017-10-31. 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 SURGERY 2 YEARS AFTER PRIMARY DUE TO IMPINGEMENT BETWEEN THE POSTERIOR NECK OF THE STEM AND THE LATERAL SIDE OF THE CUP. THE STEM WAS FOUND MOBILIZED AND IT WAS EASY REMOVE IT, THE CUP WAS OSSEOINTEGRATED AND REMOVED WITH CUP-REMOVAL INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782573 AMISTEM H CEMENTLESS STEM SIZE 7 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 124058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention