BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 9932110 · Received April 7, 2020

    Report

    Report Number
    3005180920-2020-00221
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 7, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06-APRIL-2020: LOT 141478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUN-2014. EXPIRATION DATE: 30.04.2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 5 YEARS AND 4 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN AN ELDERLY MAN ((B)(6) YEAR OLD). NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS OR PRESENCE OF COMORBIDITIES IS AVAILABLE. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF BONE ALTERATIONS IN THE PROXIMAL PART OF THE FEMUR, ESPECIALLY AT THE GREATER TROCHANTER, AND THE STEM LOOKS SLIGHTLY UNDERSIZED. THE REASON OF THIS CHOICE CANNOT BE ASSESSED ON THE BASIS OF AVAILABLE INFORMATION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO RADIOLUCENCY 5 YEARS AND 4 MONTHS AFTER THE PRIMARY. THE STEM HAS BEEN REPLACED WITH A BIGGER SIZE (AMISTEM-P), THE HEAD AS WELL. THE HEAD WAS NOT A MEDACTA PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396182 STEM: AMISTEM H HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.143 141478 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention