BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/E

    MDR report key: 10654351 · Received October 9, 2020

    Report

    Report Number
    3005180920-2020-00698
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    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 21 SEPTEMBER 2020: LOT 2000182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2020. EXPIRATION DATE: 2025-02-19. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118610 LINER: MPACT FLAT PE HC LINER 36/E ACETABULAR PE LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2000182 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention