BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 1 STD

    MDR report key: 6412993 · Received March 17, 2017

    Report

    Report Number
    3005180920-2017-00114
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 15, 2017
    Report Date
    June 2, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08 MAY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE VISUAL INSPECTION WAS PERFORMED. WE CONFIRM WHAT WROTE IN THE PRELIMINARY ANALYSIS. ON THE RIM OF THE FEMORAL HEAD SOME SIGNS WERE NOTICED, PROBABLY OCCURRED DURING THE EXTRACTION IN REVISION. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ON 17 MARCH 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEMORAL REVISION IN A (B)(6) YEAR OLD WOMAN 4.5 YEARS AFTER PRIMARY CEMENTLESS THA. THE STEM IS CLEARLY RADIOGRAPHICALLY LOOSE; THE IMPLANT APPEARS TO BE CORRECTLY POSITIONED. ONLY ONE PROJECTION IS AVAILABLE AND SHOWS A STEM POSSIBLY SLIGHTLY UNDERSIZED, BUT THIS CANNOT BE CONCLUSIVELY IDENTIFIED AS THE CAUSE FOR MOBILIZATION. THE FORMER PERFORMANCE OF THE JOINT DURING THE 4+ YEARS IS NOT REPORTED. ASEPTIC LOOSENING IS A POSSIBLE, MULTIFACTORIAL, LITERATURE-DESCRIBED ADVERSE EVENT FOLLOWING THA. THERE IS NO INDICATION IN THIS CASE THAT A FAULTY DEVICE CAUSED THE PROBLEM. ON 17 MARCH 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE X-RAY OF THE PATIENT AND COMMENTED AS FOLLOWS: THE IMAGE WAS ANALYZED. FROM THE RECEIVED IMAGE IT IS POSSIBLE TO NOTICE A HA COATING ALMOST TOTALLY ABSORBED, EXCEPT IN SOME LITTLE AREAS. THERE ARE NO PARTICULAR EVIDENT SIGNS, EXCEPT FOR SOME LITTLE SIGNS IN SOME POINTS OF NECK AND BALL HEAD, MOST PROBABLY DUE TO THE REVISION. FROM THE ANALYZED PICTURE IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 17 MARCH 2017. LOT 120446: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 APRIL 2012. EXPIRATION DATE: 2017-02-28. 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. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO THIGH PAIN WITHOUT A PARTICULAR TRIGGER. AT X-RAY EXAMINATION, SUBSIDENCE OF THE STEM WAS DETECTED. A REVISION SURGERY WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196662 AMISTEM H, HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 120446

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention