BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMHS CP

    MDR report key: 3133014 · Received May 29, 2013

    Report

    Report Number
    1020279-2013-00286
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235112 IMHS CP IMHS CP 130 D 10 X 34R KTT SMITH & NEPHEW, INC. 11BT03389

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 71661232 .5MMX32MM CAPTURED SCREW| 71684305 IMHS CP HA SUBTROC 12.7X105