BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+10

    MDR report key: 1910423 · Received November 23, 2010

    Report

    Report Number
    2249697-2010-01614
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED BY STRYKER ORTHOPAEDICS CLINICAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. ADDITIONAL FOLLOW-UP INFO MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 623-00-36F, LOT # MJJ7EV, DESCRIPTION: TRIDENT 0? X3 INSERT 36MM ID. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) EXPERIENCED AN ADVERSE EVENT FOR DEEP JOINT INFECTION AND THE ACETABULAR INSERT AND FEMORAL BEARING HEAD WERE REVISED. RELATIONSHIP TO THE DEVICE IS NOTED AS "UNCERTAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/+10 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MJKJVL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R