BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNFIT TH DUAL MOBILITY ACETABULAR CUP

    MDR report key: 8412248 · Received March 12, 2019

    Report

    Report Number
    3008668801-2019-00001
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    December 14, 2017
    Report Date
    February 19, 2019
    Manufacturer
    SERF
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIMARY IMPLANTATION (B)(6) 2014 WITH SUNFIT TH 59 AND CI 59/28 E WITH OMNILIFE SCIENCE STEM AND HEAD. PATIENT PRESENTED WITH PAIN WITH EPISODES OF CLICKING AN CLACKING. THE REVISION WAS ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205252 SUNFIT TH DUAL MOBILITY ACETABULAR CUP DUAL MOBILITY ACETABULAR CUP - METAL BACK - UNCEMENTED LZO SERF SUNFIT TH 59 1206378A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention