BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 4 STD

    MDR report key: 6339368 · Received February 17, 2017

    Report

    Report Number
    3005180920-2017-00049
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    January 18, 2017
    Report Date
    May 19, 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 (B)(4) 2017 THE MANUFACTURER OF THE ASSOCIATED CERAMIC HEAD (NOT MARKETED IN US) INVOLVED IN THIS COMPLAINT PROVIDED A DOCUMENT REVIEW, REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATION CAN NOT BE DONE. BATCH REVIEW PERFORMED ON 14 FEBRUARY 2017. LOT 141472: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 17 FEB 2017 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: TOTAL REVISION IN CEMENTLESS THA AFTER 2 YEARS. ACCORDING TO REPORT, FIRM BONE ONGROWTH HAD OCCURRED, BUT ON THE RADIOGRAPH ONLY THE DISTAL PART OF THE STEM LOOKS FIXED, AND THEREFORE THE DEVICE WAS MOBILIZED PROXIMALLY AND PAINFUL. SUCH FEMORAL ANATOMIES, IN YOUNG PATIENTS, PRESENT FREQUENTLY A SEVERE CHALLENGE FOR THA. THE ROOT CAUSE FOR THIS FAILURE CANNOT BE DETERMINED WITH CERTAINTY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 19 APRIL 2017 AND INCLUDES: THE EXPLANTS WILL NOT BE AVAILABLE FOR FURTHER INVESTIGATIONS.

    Description of Event or Problem · 1

    REVISION SURGERY 25 MONTHS AFTER PRIMARY WAS NECESSARY DUE TO PAIN. NO INFECTION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121696 AMISTEM H, HA COATED STEM SIZE 4 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 141472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention