BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA

    MDR report key: 6121131 · Received November 22, 2016

    Report

    Report Number
    3010536692-2016-01451
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION. AGE AT PRIMARY:(B)(6), SIDE: L, PRIMARY ASA: P1-FIT AND HEALTHY, REVISION NJR INDEX NO:(B)(4), SEX: F, PRIMARY BMI: (B)(6). ADDITIONAL INFORMATION RECEIVED 10/24/2016. ALL PART NUMBER-REPORTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773220 FEMORAL HEAD BIOLOX DELTA HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. 241

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention