BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD

    MDR report key: 5104156 · Received September 25, 2015

    Report

    Report Number
    3005180920-2015-00208
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 25, 2015
    Report Date
    November 18, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 27 OCT 2015 THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2015 ON THE FOUR LOTS INVOLVED: 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 THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. COCR BALL HEAD 12/14 Ø 28 SIZE M, REF. 01.25.012 LOT. 130252 (K072857): LOT 130252: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MAY 2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VERSAFITCUP CC FLAT PE HC LINER Ø 28 / C REF. 01.26.2839HCT LOT. 124723 (K103352): LOT 124723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 FEBRUARY 2013. EXPIRATION DATE: 2017-12-31. 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. VERSAFITCUP CC LIGHT ACETABULAR SHELL Ø 48 REF. 01.26.48MBTL LOT. 124708 (NOT REGISTERED IN THE USA): LOT 124708: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 JANUARY 2013. EXPIRATION DATE: 2017-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. THROWN AWAY BY THE HOSPITAL.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 2 YEARS AFTER PRIMARY. ALL THE IMPLANTS WERE EXPLANTED., WITH THE IMPLANTATION OF A CEMENT SPACER REASON : INFECTION WITH PSEUDOMONAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634495 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 130048

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention