BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIC/EZE TR BALL GRVD 32+1

    MDR report key: 2112612 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-08847
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION IS NOT POSSIBLE AS THE INSTRUMENT WAS NOT RETURNED. CURRENT PRODUCT DESIGN INCLUDES A WIRE WITHIN THE MATERIAL SO THAT IT CAN BE LOCATED BY X-RAY SHOULD IT BECOME LOST IN THE PATIENT. (B)(4). A LOT CODE TO DETERMINE PRODUCT AGE OF THIS PARTICULAR INSTRUMENT WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    DURING FINAL TRIALING, THE 1.5 HEAD TRIAL CAME OFF THE SUMMIT STEM IMPLANT AND GOT CAUGHT BEHIND THE ACETABULUM AND TOOK 3.5 HRS TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIC/EZE TR BALL GRVD 32+1 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention