BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 7391998 · Received April 3, 2018

    Report

    Report Number
    1818910-2018-56572
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    December 21, 2017
    Report Date
    March 7, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SUBJECT: (B)(6). CLINICAL DATABASE ALERT RECEIVED FOR REVISION DUE TO INFECTION. DOI: NOT PROVIDED, DOR: (B)(6) 2017, (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234931 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. 181891

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention