BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE SYSTEM

    MDR report key: 2885231 · Received December 18, 2012

    Report

    Report Number
    2249697-2012-02732
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WILL HAVE TO GO BACK IN AGAIN AT ANOTHER TIME AND USE SOME SLEEVES WHICH ARE NOT AVAILABLE AT THIS TIME, DUE TO SEVERE BONE LOSS. SURGEON IS WAITING FOR CULTURES TO COME BACK AS THEY WERE SENT OUT TO A LAB TO WORK UP FOR POSSIBLE SUSPECTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN KNEE SYSTEM IMPLANT MEH STRYKER ORHTOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention