BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 COCR LFIT HEAD 36MM/-5

    MDR report key: 2904749 · Received December 4, 2012

    Report

    Report Number
    2249697-2012-02557
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, USED A V40 HEAD ON C TAPER STEM. MISTAKE WAS CAUGHT IMMEDIATELY AND THE HEAD WAS SWITCHED TO C TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/-5 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MLD71Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other