BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2821791 · Received November 6, 2012

    Report

    Report Number
    1818910-2012-24139
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    June 24, 2014
    Report Date
    December 9, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    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

    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 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 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

    PER FDA'S REQUEST THIS MEDWATCH IS BEING RESENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN, SORENESS, AND DISCOMFORT; CLUNKING NOISE OF THE LEFT HIP; DIFFICULTY WALKING, STANDING UP AND MOVING AFTER SITTING FOR ANY LENGTH OF TIME AND PERFORMING ROUTINE ACTIVITIES; INABILITY TO LEAD A NORMAL LIFE, ANXIETY, AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

    Description of Event or Problem · 1

    UPDATE REC'D 12/9/14 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB. THE MDR DECISION FOR THE SLEEVE IS NOW BEING REPORTED AND THE STEM IS NOW BEING ADDED FOR ELEVATED METAL IONS.

    Description of Event or Problem · 1

    UPDATE 9/24/15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, NORMAL METAL ION LEVELS AND CORROSION ON THE TRUNNION. THE COMPLAINT WAS UPDATED ON:10/19/2015.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN, SORENESS, AND DISCOMFORT; CLUNKING NOISE OF THE LEFT HIP; DIFFICULTY WALKING, STANDING UP AND MOVING AFTER SITTING FOR ANY LENGTH OF TIME AND PERFORMING ROUTINE ACTIVITIES; INABILITY TO LEAD A NORMAL LIFE, ANXIETY, AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. DOI: (B)(6) 2008 DOR: NONE REPORTED (LEFT HIP). DOB: (B)(6). PATIENT IS A RESIDENT OF (B)(6). UPDATE RECEIVED: 24TH JUNE 2014 - ADDED REVISION DATE: (B)(6) 2014, ADDED HOSPITALS: (B)(6), ADDED IMPLANT DATE: (B)(6) 2008, ADDED PATIENT HEIGHT, ADDED PATIENT WEIGHT, ADDED PATIENT AGE, ADDED FURTHER DESCRIPTION: PATIENT REVISED DUE TO PAINFUL LEFT TOTAL HIP. COMPONENT WERE WELL FIXED AND ADDED ALL PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2549257

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R