BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 5

    MDR report key: 7380664 · Received March 29, 2018

    Report

    Report Number
    3005180920-2018-00193
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 2, 2018
    Report Date
    March 29, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 MARCH 2018; LOT 103232: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 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 A SIMILAR REPORTED EVENT

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT. THE SURGEON REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224788 AMISTEM H HA COATED STD STEM SIZE 5 COATED STD STEM LZO MEDACTA INTERNATIONAL SA 103232 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention