BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø40/F

    MDR report key: 19971501 · Received August 13, 2024

    Report

    Report Number
    3005180920-2024-00622
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812262
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-JUL-2024. LOT 2202303: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2022. EXPIRATION DATE: 2027-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF 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
    2514205 MPACT FLAT PE HC LINER Ø40/F HIP LINER LZO MEDACTA INTERNATIONAL SA 2202303 07630030812262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention