BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/F

    MDR report key: 12126621 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00556
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 13, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JUNE 2021: LOT 2013106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2026-01-03. 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 · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 20 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR HEAD AND MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027038 LINER: MPACT FLAT PE HC LINER 36/F FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2013106 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention