BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 62/28

    MDR report key: 13236216 · Received January 12, 2022

    Report

    Report Number
    3005180920-2022-00012
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807503
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22.12.2021: LOT 2103104: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 9-JUN-2021. EXPIRATION DATE: 2026-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN 1 AND HALF A MONTH AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101013 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 62/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2862MHC 2103104 07630030807503

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention