BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3851903 · Received June 5, 2014

    Report

    Report Number
    1020279-2014-00349
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR FROM THE AVAILABLE INFORMATION THE EXACT CAUSE FOR THE FRACTURE OF THE NECK REGION OF THE HIP STEM. A FRACTURE IN THE NECK REGION MAY OCCUR IF THE MECHANICAL LOADS APPLIED TO THE STEM EXCEED THE STRENGTH OF THE MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329178 SYNERGY FEMORAL COMPONENT JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization (B)(4)