BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 3010235 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14033
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    April 11, 2011
    Report Date
    March 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED INFECTION. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    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

    MAUDE REPORT (B)(6) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT EXPERIENCED AN ABSCESS ON THEIR LEFT THIGH, PAIN, AND CLICKING, ELEVATED CHROMIUM AND COBALT LEVELS. PATIENT WAS REVISED IN 2011 DUE TO INFECTION AND WAS REIMPLANTED THE SAME YEAR. FOLLOWING THE REIMPLANTATION, PATIENT CONTINUED TO HAVE AN INFECTION IN THE HIP AND SUFFERED SIGNIFICANT PAIN. THE PATIENT APPARENTLY HAS NOT BEEN REVISED A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114188 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KXA DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention