BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE3

    MDR report key: 8315261 · Received February 7, 2019

    Report

    Report Number
    3005180920-2019-00031
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 7, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PARTIAL HIP REVISION SURGERY OCCURRED 5 YEARS AND 11 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) HEAVY ((B)(6)) PATIENT. RADIOGRAPHIC IMAGES SHOW REGIONS OF REDUCED BONE DENSITY IN THE PROXIMAL FEMUR. NO RADIOGRAPHIC HISTORY IS AVAILABLE, SO THE POSTOPERATIVE XRAY CANNOT BE EVALUATED, BUT WE CANNOT SEE ANY PARTICULAR REASON FOR THIS BONE LOSS. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP REPLACEMENT AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 07 FEBRUARY 2019: LOT 123307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2012. EXPIRATION DATE: 2017-09-30. 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 5 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108719 STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 123307 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention