BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL-PLUS MIA

    MDR report key: 2955561 · Received February 11, 2013

    Report

    Report Number
    9613369-2013-00008
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    AARAU SWITZERLAND MANUFACTURING 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59573 SL-PLUS MIA SL-PLUS MIA STEM LATERAL 3 NON-CEM JDH AARAU SWITZERLAND MANUFACTURING SITE A0804030

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization (B)(4) - ANA.NOVA II CUP - (B)(4)| (B)(4) - ANA.NOVAII DYS-INSERT - (B)(4)| (B)(4) - CERAMIC HEAD - (B)(4)