BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS ACETABULAR LINER

    MDR report key: 3236857 · Received July 12, 2013

    Report

    Report Number
    3009701876-2013-00010
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 12, 2013
    Manufacturer
    PIPELINE ORTHOPEDICS LLC
    Product Code
    OQH
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT INFECTED FROM A PREVIOUS SURGERY REQUIRED AN ACETABULAR LINER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323857 RESTORIS ACETABULAR LINER OQH PIPELINE ORTHOPEDICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention