BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER 40/G

    MDR report key: 11999150 · Received June 15, 2021

    Report

    Report Number
    3005180920-2021-00488
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812286
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 MAY 2021: LOT 1900227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901893 MPACT FLAT PE HC LINER 40/G HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.32.4052HCT 1900227 07630030812286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention