BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2770816 · Received October 3, 2012

    Report

    Report Number
    1818910-2012-75936
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    January 13, 2015
    Report Date
    January 13, 2015
    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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISABILITY AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISABILITY AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE 13 JAN 2015 - DER RCVD. UPDATED DOR, PATIENT HEIGHT AND WEIGHT, SALES REP INFORMATION AND ADDED SLEEVE AND UNKNOWN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2512749

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R