BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28

    MDR report key: 10919853 · Received November 30, 2020

    Report

    Report Number
    3005180920-2020-00856
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 NOVEMBER 2020: LOT 1900250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2019. EXPIRATION DATE: 2024-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    TWO MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR STEM AND HEAD WITH COMPETITOR PRODUCTS, AND REVISED THE VERSAFITCUP DM LINER HC 56/28 WITH A VERSAFITCUP DM LINER HC 56/28. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384862 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28 VERSAFITCUP DM LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 1900250 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention