BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 11420961 · Received March 5, 2021

    Report

    Report Number
    3005180920-2021-00170
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    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 16 FEBRUARY 2021: LOT 111767: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JULY-2011. EXPIRATION DATE: 2016-06-30. 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 SINCE 1-1-2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. 9 YEARS AND 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE STEM, HEAD, LINER, AND CUP WITH COMPETITOR IMPLANTS. THE SURGEON DECIDED TO REVISE THE CUP BECAUSE IN THE X-RAYS, IT APPEARED LOOSE. HOWEVER, DURING SURGERY, IT WAS OBSERVED THAT NOTHING WAS WRONG WITH THE CUP, BUT THE SURGEON DECIDED TO REVISE IT ANYWAY. X-RAYS ARE NOT AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315943 STEM: AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 111767 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention