BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/+12

    MDR report key: 3972674 · Received August 1, 2014

    Report

    Report Number
    0002249697-2014-02967
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    March 4, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES LOOSENING OF THE UNKNOWN CONE BODY. THE CURRENT DEVICE IS THE HEAD WHICH WAS NOT INVOLVED IN THE LOOSENING AND IS THEREFORE CONSIDERED CONCOMITANT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION BECAUSE HE CONTINUED TO HAVE SIGNIFICANT PAIN IN RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION BECAUSE HE CONTINUED TO HAVE SIGNIFICANT PAIN IN RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450400 V40 COCR LFIT HEAD 40MM/+12 IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJNX81

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention