BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR SHELL CC TRIO Ø 50

    MDR report key: 18451682 · Received January 5, 2024

    Report

    Report Number
    3005180920-2023-01070
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807763
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 JANUARY 2024. LOT 2000131: 200 ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2020. EXPIRATION DATE: 2025-MAY-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 199 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. ABOUT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507232 ACETABULAR SHELL CC TRIO Ø 50 ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 2000131 07630030807763

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention