BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 STD

    MDR report key: 6300131 · Received February 3, 2017

    Report

    Report Number
    3005180920-2017-00016
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 5, 2017
    Report Date
    April 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 APRIL 2017, THE (B)(4) PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE LINER SHOWED SOME GROOVES PROBABLY OCCURRED DURING THE EXTRACTION, WHILE THE FORTE CERAMIC BALL HEAD SHOWED SOME SIGNS ON THE BASE, PROBABLY DUE TO REVISION TOO. NO OTHER SIGNS WERE NOTICED AND FROM THE RECEIVED PIECES IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 17 JANUARY 2017 AND INCLUDES: THE SURGEON NOTICED RADIOLUCENCY AROUND THE PROXIMAL PART OF THE STEM. THE SURGEON REVISED THE HEAD AND LINER AND PUT BONE GRAFT AROUND THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 18 JANUARY 2017 AND INCLUDES: THE STEM WAS NOT REVISED BECAUSE IT WAS WELL FIXED. ON 20 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS HEAD AND DM "LINER" WERE REPLACED IN THIS CEMENTLESS DM THA IN A WOMAN OF (B)(6), 7 YEARS AFTER PRIMARY. RADIOLUCENT PROXIMAL LINES WERE FOUND AROUND THE STEM AND THE CONSERVATIVE CHOICE OF GRAFTING THE SPACE BETWEEN STEM AND BONE WAS TAKEN. IT COULD BE ASSUMED THAT IN ABSENCE OF THIS INTERVENTION THE STEM WOULD HAVE PROGRESSED TOWARDS MOBILIZATION. THE REASONS FOR THIS UNFAVOURABLE EVOLUTION ARE NOT DETERMINED. ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING PRIMARY THA, DESCRIBED IN LITERATURE, AND IN MANY CASES THE CAUSES CANNOT BE DETERMINED WITH CERTAINTY. BATCH REVIEW PERFORMED ON 31 JANUARY 2017. LOT 092519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2009. EXPIRATION DATE: 2014-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN WAS UNKNOWN AT THIS TIME. AT REVISION, THE SURGEON NOTICED RADIOLUCENCY AROUND THE PROXIMAL PART OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83112 AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 092519

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention