BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

    MDR report key: 7074507 · Received December 1, 2017

    Report

    Report Number
    3005180920-2017-00720
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 3, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 17TH NOV 17 THE MEDICAL AFFAIRS MADE THE FOLLOWING INVESTIGATION: HIP REVISION SURGERY OCCURRED 1 YEAR AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM AND SIGNS OF STRESS SHIELDING SUGGESTING MOBILIZATION OF THE STEM. A VERY SIGNIFICANT BONE REMODELING PROCESS TOOK PLACE IN A SHORT TIME, AFFECTING EVENT THE LATERAL EXTERNAL CORTEX OF THE FEMUR: SOMETIMES THESE FINDING S ARE RELATED TO SILENT INFECTIONS. THE IMAGES ARE COMPATIBLE WITH A LOCAL INFLAMMATORY PROCESS TAKING PLACE; THE STEM SANK SIGNIFICANTLY AND GOT LOOSE. IN THIS CASE, THE REAL CAUSE OF THE FAILURE CANNOT BE DETERMINED. ON 1ST DEC 2017 THE R&D PROJECT MANAGER CHECKED THE IMAGES OF THE EXPLANT COMMENTING AS FOLLOWING: FROM THE RECEIVED IMAGE THE STEM APPEARED WITHOUT ANY PARTICULAR EVIDENT SIGN. IT APPEARED JUST REMOVED FROM THE PATIENT'S FEMUR, STILL COVERED WITH BLOOD. APPARENTLY, THE HA COATING IS NOT ANYMORE VISIBLE ON THE SURFACE OF THE STEM, FIRST SIGN OF A POTENTIAL GOOD INTEGRATION WITH THE BONE. FROM THE RECEIVED PHOTO IT IS NOT POSSIBLE TO PERFORM FURTHER CONSIDERATIONS AND TO DETERMINE THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 01 DECEMBER 2017: LOT 160644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MAY 2016; EXPIRATION DATE: 2021-04-21. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY ABOUT 1 YEAR AFTER PRIMARY DUE TO AMISTEM H ASEPTIC LOOSENING WITH PRESENCE OF PSEUDOMEMBRANE. A NEW STEM WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855759 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD CEMENTLESS HA COATED STEM LZO MEDACTA INTERNATIONAL SA 160644 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention