BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 LAT

    MDR report key: 6957336 · Received October 18, 2017

    Report

    Report Number
    3005180920-2017-00587
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 24, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 OCTOBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 3 YEARS AFTER PRIMARY CEMENTLESS THA. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 AND SIGNS OF STRESS SHIELDING. THE STEM LOOKS SLIGHTLY UNDERSIZED PROBABLY DUE TO A PARTICULAR PATIENT ANATOMY BUT THE REASON OF THIS CHOICE CANNOT BE ASSESSED ONLY BY ANTEROPOSTERIOR PROJECTIONS. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED MID-TERM ADVERSE EVENT AFTER CEMENTLESS THA: CAUSES ARE OFTEN UNKNOWN. IN THIS CASE, THE REASON OF THIS EVENT CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 16 OCTOBER 2017. LOT 131646: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JULY 2013. EXPIRATION DATE: 2018-06-30. 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE (B)(6) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE STEM HAD THE COATING ALMOST TOTALLY ABSORBED, EXCEPT FOR SOME AREAS IN THE PROXIMAL PART. SOME SMALL FIBROTIC TISSUE WERE NOTICED IN THE MACROSTRUCTURES OF THE STEM ESPECIALLY IN THE DISTAL AREA. SCRATCHES ARE VISIBLE IN THE NECK DUE TO THE EXTRACTION; THE CERAMIC BALL HEAD SHOWED THE USUAL SIGNS OF REMOVAL IN THE RIM. FROM THE ANALYSIS OF THE COMPONENTS THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION OF THE STEM PLANNED FOR LOOSENING SUSPICIOUS. THE SURGERY WAS COMPLETED SUCCESSFULLY. LOOSENING OF THE STEM WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736762 AMISTEM H, HA COATED STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 131646 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention