BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 4

    MDR report key: 8764311 · Received July 5, 2019

    Report

    Report Number
    3005180920-2019-00546
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885648
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JUN 2019: LOT 180818: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-"LUG"-2018. EXPIRATION DATE: 2023-06-24. 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

    REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY SUBSIDED STEM. THE SURGEON REVISED THE STEM, BALL HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558331 STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 180818 07630030885648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention