BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM HA COATED STD STEM SIZE 5

    MDR report key: 10263651 · Received July 13, 2020

    Report

    Report Number
    3005180920-2020-00418
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 121541: 60 ITEMS MANUFACTURED AND RELEASED ON 02-JUL-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 SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 7 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728444 AMISTEM HA COATED STD STEM SIZE 5 HIP UNCEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.135 121541 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention