BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2

    MDR report key: 18020055 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00819
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 OCTOBER 2023. LOT 140006: (B)(4) MANUFACTURED AND RELEASED ON 18-MAR-2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 8 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691348 STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2 HIP STD STEM LZO MEDACTA INTERNATIONAL SA 140006 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention