BEUDAMED
    FDA Adverse Event Summary report: N

    CI../..X LINER FOR NOVAE® DUAL MOBILITY ACETABULAR CUP

    MDR report key: 5497811 · Received March 14, 2016

    Report

    Report Number
    3008668801-2016-00002
    Date Received
    March 14, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 9, 2016
    Manufacturer
    SERF
    Product Code
    LZO
    PMA / PMN Number
    K142675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERF CI/X LINER IS NOT INVOLVED IN THE SYSTEM FAILURE BUT IT HAD TO BE REPLACE DUE TO THE FEMORAL HEAD RETENTIVITY SYSTEM.

    Description of Event or Problem · 1

    PATIENT FELL EARLY ON 2016 SURGERY, THE STEM SUBSIDED. THERE WAS BONY INGROWTH EVEN ON SUBSIDED STEM. THIS WAS A RECENT REVISION OF BOTH OMNI AND SERF PRODUCT DUE TO INITIALLY, A PATIENT FALL. IN THE REVISION THE ORIGINAL OMNI FEMORAL HEAD AND STEM WERE REVISED ALONG WITH THE SERF INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153191 CI../..X LINER FOR NOVAE® DUAL MOBILITY ACETABULAR CUP TOTAL HIP PROSTHESIS - ACETABULAR COMPONENT LZO SERF H6-24928 20180

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R