BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT SIZE 6

    MDR report key: 11907143 · Received May 31, 2021

    Report

    Report Number
    3005180920-2021-00446
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 2, 2021
    Report Date
    May 31, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804229
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MAY 2021: LOT 173450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2017. EXPIRATION DATE: 2022-10-30. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: FEMORAL COMPONENT (STEM, HEAD AND LINER) REVISION PERFORMED 2 YEARS AND 4 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN AN ELDERLY MAN ((B)(6) YEAR OLD). 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 OF FEMORAL STEM DUE TO ASEPTIC LOOSENING 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY ON AN ACTIVE PATIENT THAT UNDERWENT OSTEOTOMIES OF THE FEMUR IN THE PAST DUE TO DYSPLASIA. THE STEM WAS FOUND GROSSLY LOOSE AND EXCHANGED TO QUADRA R. LINER WAS ALSO EXCHANGED TO CONVERTOR AND DUAL MOBILITY AS OF SURGEON PREFERENCE FOR THE REVISION CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803154 STEM: AMISTEM H HA COATED LAT SIZE 6 CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 01.18.146 173450 07630030804229

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention