BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3173403 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-06373
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    August 22, 2013
    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

    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.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - SALES REP REPORTED REVISION PROCEDURE. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS BEEN AND/OR WILL BE FORCED TO UNDERGO A REVISION SURGERY. IT IS FURTHER ALLEGED THE PATIENT WAS IMPLANTED WITH A DEVICE THAT IS OR HAS BEEN SHEDDING METAL DEBRIS INTO HER BODY AND HAS CAUSED AND/OR WILL CAUSE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273919 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2549806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other