BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 54

    MDR report key: 12133519 · Received July 8, 2021

    Report

    Report Number
    3005180920-2021-00547
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807787
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08.06.2021: LOT 2010283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-MAR-2021. EXPIRATION DATE: 2025-12-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 11 DAYS AFTER THE PRIMARY DUE TO HIP LUXATION CAUSED BY MOBILIZED CUP. THE SURGEON REVISED THE CUP, INLAY AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033537 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 54 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0054 2010283 07630030807787

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention