BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 4 LAT

    MDR report key: 4297174 · Received November 21, 2014

    Report

    Report Number
    3005180920-2014-00163
    Event Type
    Injury
    Date Received
    November 21, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 4 LAT. REF. 01.18.144/ LOT# 112386 ((B)(4) STEMS PRODUCED): NO ANOMALIES FOUND RELATED TO THE PROBLEM OCCURRED. A (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. THE SAME FORGED STEMS - RAW MATERIAL LOT "MAT6561" - WERE USED TO MAKE OTHER THREE LOTS OF FINISHED AMISTEM H STEMS SIZE 4, FOR A TOTAL OF (B)(4) FURTHER STEMS (SO (B)(4) TOTALLY). (B)(4). THE RETRIEVED BROKEN STEM WAS DIMENSIONALLY CHECKED IN OUR QUALITY CONTROL DEPARTMENT AND THE NECK DIMENSIONS RESULTED TO BE IN ACCORDANCE WITH THE SPECIFICATIONS. IT WAS REPORTED THAT AN INTERMEDIATE REVISION SURGERY WAS PERFORMED ON 10/11/2013 DUE TO A LUXATION: AT THAT TIME, THE SURGEON KEPT THE STEM AND THE CUP IN PLACE, REPLACING BALL HEAD AND LINER ONLY. MEDACTA WAS NOT INFORMED ABOUT THIS REVISION. SIMILAR TO THE OTHER TWO PREVIOUS CASES OF BREAKAGES OF THE NECKS OF STEMS MANUFACTURED BY MEDACTA (ONE REPORTED TO FDA WITH MDR # 2012-00086, THE OTHER OF A STEM NOT MARKETED IN THE USA), THE ROOT CAUSE SEEMS LIKELY ASSOCIATED TO DAMAGES TO THE NECK DURING THE FIRST REVISION THAT LED TO ITS BREAKAGE MONTHS LATER. THE STEM HAS BEEN SENT TO AN INDEPENDENT LABORATORY FOR ANALYSIS AND A FOLLOW UP WILL BE SUBMITTED WITH THE RESULTS OF THESE ANALYSIS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758099 AMISTEM H FEMORAL STEM SIZE 4 LAT FEMORAL CEMENTLESS STEM LAT LZO MEDACTA INTERNATIONAL SA 112386

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention