BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2833837 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-25035
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    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. REF. (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. (B)(4).

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT SUFFERS FROM ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    (B)(4). LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM ELEVATED METAL ION LEVELS.(B)(6).UPDATE 11 JULY 2014 - DER RCVD - UPDATED DOR, SURGEON / HOSPITAL DETAILS AND ADDED 3 PRODUCTS. REASON FOR REVISION: PAIN AND BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2247439

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R