BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 8

    MDR report key: 8266709 · Received January 22, 2019

    Report

    Report Number
    3005180920-2018-01119
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    December 23, 2018
    Report Date
    January 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803307
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JANUARY 2019: LOT 181836: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JUNE 2018. EXPIRATION DATE: 2023-06-03. 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. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 22 JANUARY 2019: MPACTACETABULAR SHELL Ø60 TWO-HOLES REFERENCE 01.32.160DH (K132879). CERAMIC LINER NOT MARKETED IN US.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 3 MONTHS AFTER PRIMARY, DUE TO INFECTION. PATHOGEN IS PROTEUS. THE STEM WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60057 MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 8 CEMENTLESS ANATOMICAL STEM LZO MEDACTA INTERNATIONAL SA 181836 07630030803307

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention