BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN V40 36, +0 COCR HEAD

    MDR report key: 2833004 · Received October 30, 2012

    Report

    Report Number
    2249697-2012-02129
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS: MFR #: 2249697-2012-02128.

    Description of Event or Problem · 1

    THE JOURNAL OF BONE AND JOINT SURGERY, INC. 2012 ARTICLE STATES THAT ADVERSE LOCAL TISSUE REACTIONS CAN OCCUR SECONDARY TO METAL DEBRIS RESULTING FROM CORROSION OF THE MODULAR HEAD-NECK TAPER OF METAL ON POLYETHYLENE TOTAL HIP PROSTHESIS. THESE REACTIONS APPEAR TO BE QUITE SIMILAR TO THOSE REPORTED IN PATIENTS WITH METAL-ON-METAL BEARING SURFACE, SERUM METAL LEVELS WERE ABNORMAL IN EVERY CASE, AND WITH AN ELEVATION OF COBALT WERE ABNORMAL IN EVERY CASE WITH AN ELEVATION OF COBALT CHROME LEVELS THAT WAS DIFFERENTIALLY HIGHER THAN THAT OF CHROMIUM LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN V40 36, +0 COCR HEAD IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention