BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER/NON-HOODED-NEU, MP8, HXE-PLUS, 36MM

    MDR report key: 10806473 · Received November 8, 2020

    Report

    Report Number
    1644408-2016-00891
    Event Type
    Injury
    Date Received
    November 8, 2020
    Report Date
    November 2, 2020
    Product Code
    OQH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ORIGINAL INITIAL REPORT WAS SUBMITTED AS FOLLOW UP IN ERROR.

    Description of Event or Problem · 1

    REVISION SURGERY - THIS PATIENT HAD A LIMA CASE AND LINER. THIS WAS REMOVED AND REPLACED WITH A CUSTOM HEMI PELVIS IMPLANT WITH A DJO LINER CEMENTED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271433 LINER/NON-HOODED-NEU, MP8, HXE-PLUS, 36MM OQH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention