BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT TAPER COBALT-CHROME FEMORAL HEAD

    MDR report key: 6948151 · Received October 13, 2017

    Report

    Report Number
    3010536692-2017-01328
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    May 12, 2011
    Report Date
    September 18, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE INFECTION (RIGHT). ADDITIONAL INFORMATION RECEIVED FROM NJR ON 9/18/2017. ADDED FEMORAL HEAD AND FOLLOWING INFORMATION: REVISION NJR NUMBER: (B)(4). PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727153 SLT TAPER COBALT-CHROME FEMORAL HEAD HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. 601161814

    Patients

    Seq Age Sex Outcome Treatment
    1 74.6 YR Required Intervention