BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD SIZE 7

    MDR report key: 11885811 · Received May 26, 2021

    Report

    Report Number
    3005180920-2021-00437
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    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 10 MAY 2021: LOT 102743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2010. EXPIRATION DATE: 2015-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: FEMORAL COMPONENT REVISION PERFORMED 10.5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN (B)(6) YEAR OLD MAN. 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 PERFORMED 10 YEARS 6 MONTHS AFTER THE PRIMARY DUE TO ASEPTIC STEM LOOSENING. STEM AND HEAD SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787180 STEM: AMISTEM H HA COATED STD SIZE 7 FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.137 102743 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention