BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 2860350 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-83203
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    November 16, 2012
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 181910-2012-28320. THIS REPORT, 181910-2012-83203, WILL BE REJECTED. 181910-2012-28320 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM VERY SERIOUS BODILY INJURY, CHROMIUM COBALT POISONING, METALLIC TASTES, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY FEMORAL HEAD TOTAL HIP REPLACEMENT KXA DEPUY INTL., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other