BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 2800005 · Received October 22, 2012

    Report

    Report Number
    1818910-2012-26516
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    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

    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. NOT RETURNED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM, CONSCIOUS PAIN AND SUFFERING AND LOSS OF EARNINGS. (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE LEFT SIDE. PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. (B)(6) 2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE RIGHT SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 55 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2609147

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other