BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STRYKER TIBIAL COMPONENT

    MDR report key: 2884938 · Received December 12, 2012

    Report

    Report Number
    2249697-2012-02608
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT - DESCRIPTION: STRYKER FEMORAL COMPONENT, CAT #UNK, LOT #UNK; DESCRIPTION: STRYKER PATELLA, CAT #UNK, LOT #UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE SUBJECT IS ENROLLED IN THE (B)(4) STUDY. THE SUBJECT UNDERWENT A REVISION OF THEIR PRIMARY STRYKER KNEE SYSTEM ON (B)(6) 2012 DUE TO SEPTIC FAILURE OF THE KNEE AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK STRYKER TIBIAL COMPONENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention