BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED CORAIL STEM

    MDR report key: 3141356 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17740
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    February 24, 2013
    Report Date
    May 23, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    FROM THE COMMUNICATED ELEMENTS, NO ANALYSIS COULD BE CARRIED OUT BECAUSE NO SUFFICIENT INFORMATION WAS PROVIDED (NO PRODUCT RETURNED, NO BATCH NUMBER COMMUNICATED). THE ROOT CAUSE IS UNDETERMINED. BASED ON THE ABOVE ELEMENTS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WE CLOSE THIS COMPLAINT AS UNDETERMINED AND WILL RE-OPEN IT IF ANY RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REVISION OF A CORAIL STEM TO A KAR STEM DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244710 UNIDENTIFIED CORAIL STEM HIP STEM KWA DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention