BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1921846 · Received December 13, 2010

    Report

    Report Number
    1020279-2010-00353
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHROMIUM AND IRON METAL TRANSFER WAS LIKELY DUE TO CONTACT WITH A STAINLESS STEEL INSTRUMENT DURING EXTRACTION. THE FEATURES OBSERVED ON THE IMPLANT WERE CONSISTENT WITH THE REPORTED STEM SUBSIDENCE. NO OTHER REMARKABLE FEATURES WERE SEEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SYN POR FEM COMP SZ 13 JDH SMITH & NEPHEW ORTHOPAEDICS 09AM13739

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention