BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0

    MDR report key: 10996079 · Received December 12, 2020

    Report

    Report Number
    3005180920-2020-00900
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 NOVEMBER 2020: LOT 133052: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2013. EXPIRATION DATE: 2018-08-31. 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 CLINICAL EVALUATION: FEMORAL COMPONENT (STEM, HEAD AND LINER) REVISION PERFORMED 5 YEARS AND 9 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, GENDER, GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING 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

    REVISION SURGERY FOR STEM LOOSENING 5 YEARS AND 9 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462178 STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.130 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention