BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY METAL HEAD

    MDR report key: 2945552 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-11958
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    February 20, 2012
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    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

    THIS IS A DUPLICATE REPORT OF 1818910-2012-06428. THIS REPORT, 1818910-2013-11958, WILL BE REJECTED. 1818910-2012-06428 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    (B)(4) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT THEY WERE REVISED TO ADDRESS PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS, WHICH CAUSED DETERIORATION OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50522 UNKNOWN DEPUY METAL HEAD FEMORAL HEAD KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention