BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52

    MDR report key: 9278375 · Received November 5, 2019

    Report

    Report Number
    3005180920-2019-00931
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 7, 2019
    Report Date
    November 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 OCTOBER 2019. LOT 181696: 120 ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2018. EXPIRATION DATE: 2023-04-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 116 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED 2 SCREWS, HEAD, LINER AND CUP ALMOST 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072013 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 181696 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention