BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 52

    MDR report key: 13469122 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00068
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 10, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808098
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2022. LOT 160830: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2016. EXPIRATION DATE: 2021-MAY-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018.

    Description of Event or Problem · 0

    AT 4 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER TO COMPETITORS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213000 CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 52 ACETABULAR CUP CEMENTLESS MEH MEDACTA INTERNATIONAL SA 01.26.52MB 160830 07630030808098

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention