BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS ACETABULAR LINER

    MDR report key: 3030658 · Received March 25, 2013

    Report

    Report Number
    3009701876-2013-00004
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PIPELINE ORTHOPEDICS LLC
    Product Code
    OQH
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO A WOUND INFECTION. IT WAS REPORTED IN THE COMPLAINT THAT THE INFECTION WAS BELIEVED TO BE CAUSED BY CHANGING OF THE LEG WRAP AFTER SURGERY. DURING THE REVISION, THE ACETABULAR LINER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121750 RESTORIS ACETABULAR LINER OQH PIPELINE ORTHOPEDICS LLC 186136-54 190256-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention