BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 5

    MDR report key: 9149795 · Received October 3, 2019

    Report

    Report Number
    3005180920-2019-00829
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 3, 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 10 SEPTEMBER 2019. LOT 121341: 35 ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION OF PRIMARY UNCEMENTED THA AFTER 7 YEARS. THE INFORMATION SUPPLIED IS NOT SUFFICIENT TO DRAW A FINAL CONCLUSION, BUT THE POSITION AND THE SIZE OF THE CUP APPEAR TO BE SUBOPTIMAL, THOUGH WE CANNOT EVALUATE THE REASONS THAT LED TO THIS SITUATION BECAUSE NEITHER PREOPERATIVE NOR IMMEDIATE POSTOPERATIVE IMAGES ARE AVAILABLE. THE STEM MAY ALSO HAVE BEEN CONFLICTING WITH THE PROTRUDING CUP, SO ENHANCING MOBILIZATION PATTERN, BUT IT MUST BE CONSIDERED THAT IT LASTED FOR 7 YEARS. A FINAL CONCLUSION AS TO THE REASONS OF THIS ADVERSE EVENT CANNOT BE REACHED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM, ALSO IT WAS NOTICED THAT THE CUP WAS OVERSIZED. THE SURGEON REVISED ALL COMPONENTS 7 YEARS 1 MONTH AND A HALF AFTER PRIMARY SURGERY AND REPLACED THEM WITH COMPETITOR ITEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947982 STEM: AMISTEM H HA COATED STD STEM SIZE 5 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 121341 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention