BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL-PLUS

    MDR report key: 2981527 · Received February 27, 2013

    Report

    Report Number
    9613369-2013-00016
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SMITH&NEPHEW -SWITZERLAND
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83673 SL-PLUS SL-PLUS STANDARD STEM 4 NON-CEMENTED KWY SMITH&NEPHEW -SWITZERLAND F0707832

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R OXINIUM FEMORAL 28+ 4 BALL HEAD.