BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS TOTAL HIP SYSTEM

    MDR report key: 3251803 · Received July 18, 2013

    Report

    Report Number
    3009701876-2013-00012
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 18, 2013
    Manufacturer
    PIPELINE ORTHOPEDICS LLC
    Product Code
    OQH
    PMA / PMN Number
    K112502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INCISION AND DRAINAGE PROCEDURE CONDUCTED ON PT APPROXIMATELY ONE MONTH AFTER TOTAL HIP ARTHROPLASTY SURGERY. PT SUBSEQUENTLY TREATED WITH ANTIBIOTICS. NO COMPONENTS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333938 RESTORIS TOTAL HIP SYSTEM OQH, LPH OQH PIPELINE ORTHOPEDICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention