BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED STEM SIZE 6 LAT

    MDR report key: 6245603 · Received January 12, 2017

    Report

    Report Number
    3005180920-2016-00729
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    December 13, 2016
    Report Date
    January 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: EARLY SUBSIDENCE OF FEMORAL STEM IN CEMENTLESS TOTAL HIP ARTHROPLASTY ON A (B)(6) WOMAN. EARLY SUBSIDENCE IS NORMALLY RELATED TO POSITIONING/SIZING PROBLEMS, OFTEN CONNECTED WITH ANATOMICAL PECULIARITIES, BECAUSE THE CEMENTLESS STEM CANNOT FIND ADEQUATE PRESS-FIT, AND THIS APPEARS TO BE THE CASE IN THE PRESENT CIRCUMSTANCES. NO REASON TO THINK THAT A FAULTY DEVICE ORIGINATED THIS PROBLEM. BATCH REVIEW PERFORMED ON 09 JANUARY 2017. LOT 162770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JUNE 2016. EXPIRATION DATE: 2021-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (b)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND EVENT REPORTED ON THE SAME LOT (MDR 2016-00663). NOT AVAILABLE

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE STEM HAD SUBSIDED. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE, EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30172 MASTERLOC CEMENTLESS TI COATED STEM SIZE 6 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 162770

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention