BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3951481 · Received July 22, 2014

    Report

    Report Number
    1818910-2014-24010
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 11, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN AND THAT IN OR AROUND (B)(6) 2012, THE PATIENT BEGAN EXPERIENCING SERIOUS COGNITIVE ISSUES, INCLUDING CONCENTRATION, DIFFICULTIES CONSISTING OF FORGETFULNESS AND DISORGANIZATION. THE PATIENT UNDERWENT VARIOUS PSYCHOLOGICAL AND MEDICAL TESTING. IN (B)(6) OF 2013, A BLOOD TEST RESULTS REVEALED THAT PATIENT HAD HIGH LEVELS OF CHROMIUM COBALT IN HIS BLOOD. THIS HIGH AMOUNT OF CHROMIUM COBALT WAS FROM THE IMPLANTED HIP. PATIENT HAD A REVISION SURGERY AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428485 UNKNOWN DEPUY ASR FEMORAL HEAD HIP FEMORAL HEAD KXA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention