BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52

    MDR report key: 14300054 · Received May 6, 2022

    Report

    Report Number
    3005180920-2022-00323
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 5, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON 06-APRIL-2022. LOT 2002552: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2020. EXPIRATION DATE: 2025-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 YEAR AND 1 MONTH AFTER THE PRIMARY FOLLOWING NO OSSEOINTEGRATION OF THE CUP. THE SURGEON REVISED THE MEDACTA CUP WITH A COMPETITOR CUP 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
    1412866 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52 HIP ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0052 2002552 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention