BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L

    MDR report key: 10157886 · Received June 16, 2020

    Report

    Report Number
    3005180920-2020-00340
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809255
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 29 MAY 2020: LOT 1900813: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-05-05. 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 6 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND ANOTHER COMPANY'S LINER WITH A COMPETITOR'S LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621324 BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.214 1900813 07630030809255

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention