BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3090398 · Received May 2, 2013

    Report

    Report Number
    1818910-2013-05348
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    July 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND AN INHIBITION OF THE ABILITY TO WALK; DEVICES FAILED WITH SHEDDING METAL DEBRIS IN BODY AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB, SIDE OF BODY, PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (RIGHT HIP). COMMENT: THERE IS A DOI DISCREPANCY BETWEEN LITIGATION AND THE PPD. DUE TO ACCURACY, THE DOI FROM THE LITIGATION WILL BE REPORTED. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192376 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2435198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other