BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

    MDR report key: 12751296 · Received November 4, 2021

    Report

    Report Number
    3005180920-2021-00853
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 4, 2021
    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 08 OCTOBER 2021: LOT 155814: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2016. EXPIRATION DATE: 2021-FEB-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017. ADDITIONAL COMPONENT INVOLVED: STEM: AMISTEM H 01.18.136 HA COATED STD STEM SIZE 6 (K093944) LOT. 164614. LOT 164614: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 9-NOV-2016. EXPIRATION DATE: 2021-OCT-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    AT 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE ACETABULAR AND FEMORAL COMPONENTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650524 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52 ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0052 155814 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention