BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED STEM SIZE 6 LAT

    MDR report key: 6180728 · Received December 16, 2016

    Report

    Report Number
    3005180920-2016-00663
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 16, 2016
    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

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 01 DECEMBER 2016 AND INCLUDES: THE STEM HAD BEEN UNDERSIZED IN PRIMARY. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 162770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 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 WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THAT THE STEM HAD SUBSIDED. THE PATIENT DID NOT EXPERIENCE ANY TRAUMA. THE SURGEON REVISED THE STEM AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832311 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