BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3801401 · Received May 8, 2014

    Report

    Report Number
    1818910-2014-18418
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    July 28, 2014
    Report Date
    October 27, 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
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES INJURY AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 10/27/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS PAIN. UPON REVISION, SCAR TISSUE AND ABUNDANT INFLAMMATORY TISSUE WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT FOR ELEVATED METAL ION LEVELS. STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON: 11/20/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279366 UNKNOWN DEPUY ASR FEMORAL HEAD HIP FEMORAL HEAD KXA DEPUY INTL., LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other