BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 TIBIAL TRAY IMPLANT

    MDR report key: 2831081 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02152
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.# 2249697-2012-02151.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PT'S RIGHT KNEE DUE TO LOOSE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 TIBIAL TRAY IMPLANT IMPLANT JWH STRYKER ORHTOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention