BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10738979 · Received October 27, 2020

    Report

    Report Number
    3005180920-2020-00763
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807671
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 OCTOBER 2020: LOT 133466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2013. EXPIRATION DATE: 2018-08-31. 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 SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 6 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203719 LINER: CC E CC LIGHT FLAT PE HC LINER 36 / E ACETABULAR PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.26.3644HCT 133466 07630030807671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention