BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 8877725 · Received August 9, 2019

    Report

    Report Number
    3005180920-2019-00670
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JULY 2019: LOT 151435: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUN-2015. EXPIRATION DATE: 2020-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: STEM AND HEAD REVISION PERFORMED 3 YEARS AND 7 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. NO INFORMATION CONCERNING LEVEL OF ACTIVITY, PATIENT GENERAL HEALTH STATUS AND COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES IN GRUEN ZONE 1 AND 7 ARE VISIBLE. 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

    WE WERE TOLD ON (B)(6) 2019 THAT THE REVISION WILL TAKE PLACE ON (B)(6) 2019 (AFTER 3 YEARS AND 6 MONTHS FROM THE PRIMARY), DUE TO STEM LOOSENING. THE STEM AND THE FEMORAL HEAD HAVE BEEN REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671741 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 151435 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention