BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 2061772 · Received April 19, 2011

    Report

    Report Number
    9613369-2011-00022
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    SMITH & NEPHEW AARAU SWITZERLAND SITE
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS SL-PLUS MIA STEM LATERAL 4 NON-CEM JDH SMITH & NEPHEW AARAU SWITZERLAND SITE A0709718

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R