BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM HA COATED STD STEM SIZE 5

    MDR report key: 9254775 · Received October 30, 2019

    Report

    Report Number
    3005180920-2019-00919
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 9 OCTOBER 2019: LOT 103232: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3 DECEMBER 2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENT MDR: [2017-00514] AND [2018-00193]. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY PERFORMED 1 YEAR AND 7 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY DUE TO A SUBSIDED STEM. POST-REVISION X-RAYS PROVIDED DON'T ALLOW A PROPER INVESTIGATION OF THE CAUSES OF THIS EVENT. NO CONCLUSION CAN BE DRAWN ON THE BASIS OF AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 7 MONTHS FROM THE PRIMARY DUE TO INSTABILITY CAUSED BY A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049168 STEM: AMISTEM HA COATED STD STEM SIZE 5 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 103232 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention