BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIC/EZE TR BALL GRVD 32+1

    MDR report key: 1192028 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04442
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION IS NOT POSSIBLE AS THE INSTRUMENT REMAINS IN THE PATIENT. A LOT CODE TO DETERMINE PRODUCT AGE WAS NOT KNOWN. 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. A TWO-YEAR COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTS OF ANY KIND AGAINST THIS PRODUCT CODE. 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.

    Description of Event or Problem · 1

    DURING TRIALING, THE TRIAL BALL FELL OFF WHEN THE HIP WAS DISLOCATED. TRIAL HEAD BALL COULD NOT BE FOUND AND WAS LEFT IN THE PATIENT.

    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 63 YR Other