BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL-PLUS

    MDR report key: 3111004 · Received May 14, 2013

    Report

    Report Number
    9613369-2013-00042
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    January 1, 1901
    Report Date
    May 13, 2013
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212315 SL-PLUS SL-PLUS STEM LATERAL 1 NON-CEMENTED KWY SMITH&NEPHEW, INC C1017766

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R (B)(4) - BIOLOX CE BALL HEAD - (B)(4)