BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F

    MDR report key: 10493017 · Received September 4, 2020

    Report

    Report Number
    3005180920-2020-00579
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 4, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807688
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 01.SEP.2020: LOT 1910304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2025-01-05. 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 SINCE 2016.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO INFECTION, 20 DAYS AFTER THE PREVIOUS REVISION SURGERY (PREVIOUSLY LINER AND HEAD WERE REVISED DUE TO DISLOCATION). THE INLAY WAS A MEDACTA PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957169 LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA 01.26.3648HCT 1910304 07630030807688

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention