BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6

    MDR report key: 10389667 · Received August 11, 2020

    Report

    Report Number
    3005180920-2020-00507
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885662
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 173201: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2017. EXPIRATION DATE: 2022-11-15. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON WAS UNABLE TO REMOVE THE STEM AND HAD TO PERFORM AN OSTEOTOMY OF THE FEMUR TO REMOVE THE STEM THUS, CABLES WERE NEEDED. ALSO THE HEAD HAS BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY 2 YEARS AND 3 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853932 STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.39.206 173201 07630030885662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention