BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL PLUS STEMS

    MDR report key: 1823236 · Received September 2, 2010

    Report

    Report Number
    9613369-2010-00041
    Event Type
    Injury
    Date Received
    September 2, 2010
    Report Date
    September 1, 2010
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AARAU SWITZERLAND
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL PLUS STEMS STEM JDH SMITH & NEPHEW ORTHOPAEDICS AARAU SWITZERLAND 75002695 F0707615

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R (B)(4), LOT # 69076| (B)(4), LOT# 51752