BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT SPS

    MDR report key: 3053474 · Received April 11, 2013

    Report

    Report Number
    1020279-2013-00205
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATELLA PEG SHEARING OFF AT CEMENT INTERFACE. A REVISION SURGERY WAS PERFORMED TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156971 IMPLANT SPS GEN II RESURF PATELLA 38MM JWH SMITH & NEPHEW, INC. 04LM07895

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention