BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28

    MDR report key: 14683691 · Received June 14, 2022

    Report

    Report Number
    3005180920-2022-00466
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    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 31 MAY 2022. LOT 2113066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN 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
    1687865 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28 HIP ACETABULAR LINER PE DOUBLE MOBILITY MEH MEDACTA INTERNATIONAL SA 01.26.2854MHC 2113066 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention