BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 36MM ID US CRMC LINER 54

    MDR report key: 5262296 · Received December 2, 2015

    Report

    Report Number
    1020279-2015-00828
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    November 19, 2015
    Report Date
    May 19, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA P030022/S008. (B)(4). CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION HIP SURGERY WAS PERFORMED DUE TO CLICKING, PAIN, AND BECAUSE THE CERAMIC LINER WAS BROKEN INTO NUMEROUS PIECES AND EMBEDDED IN SYNOVIUM. THE LINER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792273 R3 36MM ID US CRMC LINER 54 ACETABULAR LINER JDH SMITH & NEPHEW, INC. 08DT19386R

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R