BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2761129 · Received September 26, 2012

    Report

    Report Number
    1818910-2012-76019
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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. DEPUY CONSIDERS THE COMPLAINT COMPLETE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED PAIN AND DISABILITY ON ACCOUNT OF HER ASR LEFT HIP IMPLANT. LITIGATION FURTHER ALLEGES THAT THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD AS DETERMINED FROM BLOOD TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL 1993540

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other