BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2659450 · Received July 18, 2012

    Report

    Report Number
    1818910-2012-17015
    Event Type
    Injury
    Date Received
    July 18, 2012
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    BILATERAL PATIENT. LITIGATION PAPERS ALLEGE THAT PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS. PATIENTS PRELIMINARY DISCLOSURE FORM WAS RECEIVED ON 6/25/2012, WHICH PROVIDED PART/LOT INFORMATION FOR BOTH SIDES.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: BILATERAL PATIENT. LITIGATION PAPERS ALLEGE THAT PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS. PATIENT'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED ON 6/25/2012, WHICH PROVIDED PART/LOT INFORMATION FOR BOTH SIDES. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP). DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP). **PATIENT IS A RESIDENT OF (B)(6). UPDATE - DER RCVD 20 MAY 2014. UPDATED REVISION DATE / SURGEON / HOSPITAL FOR LEFT SIDE AND PRODUCT INFORMATION FOR BOTH SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2551513

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R