BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2736382 · Received September 8, 2012

    Report

    Report Number
    1818910-2012-75018
    Event Type
    Death
    Date Received
    September 8, 2012
    Date of Event
    June 19, 2018
    Report Date
    August 9, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4) IS BEING INDICATED FOR BLOOD HEAVY METAL INCREASED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 ALLEGED THE PATIENT SUFFERED PAIN, ELEVATED COBALT LEVELS AND DISCOMFORT AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, ELEVATED COBALT LEVELS AND DISCOMFORT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE: 1/25/2013 - PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL IONS WHICH CONTRIBUTED TO HIS HEART AND LIVER CONDITIONS. THERE WERE NO LAB RESULTS PROVIDED FOR THE ALLEGED ELEVATED METAL IONS; HOWEVER, PATIENT WAS NOTED TO HAVE DECEASED BASE ON THE DEATH EXAM NOTE AND PHYSICAL EXAM NOTE ON (B)(6) 2018. DOI: (B)(6) 2008; DOR: (B)(6) 2018; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL LTD - 8010379 2372513

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| O