BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID STEM LAT SIZE 11

    MDR report key: 18482244 · Received January 10, 2024

    Report

    Report Number
    3005180920-2023-01082
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 7, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888830
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 JANUARY 2024. LOT 2100585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUNE-2021. EXPIRATION DATE: 2026-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR STEM LOOSENING AT ABOUT 9 MONTHS POST-PRIMARY. STEM AND HEAD SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987956 STEM: SMS SOLID STEM LAT SIZE 11 STEM LATERALIZED CEMENTLESS LZO MEDACTA INTERNATIONAL SA 2100585 07630030888830

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention