BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2241710 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17640
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    October 6, 2014
    Report Date
    October 20, 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
    MO, 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.

    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 THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE SEVERE AND PERMANENT PHYSICAL PAIN, SUFFERING, INJURY AND DISABILITY, POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES, DIMINUTION IN EARNING CAPACITY, LOST WAGES, MEDICAL MONITORING EXPENSES, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, METALLOSIS.

    Description of Event or Problem · 1

    UPDATE REC'D 10/20/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, GRAYISH CLOUDY FLUID, EXTENSIVE SCAR TISSUE, AND OSTEOLYTIC FIBROUS MATERIAL WITHIN THE RIM OF THE HEAD WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 11/19/14.

    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 PAPERS ALLEGE SEVERE AND PERMANENT PHYSICAL PAIN, SUFFERING, INJURY AND DISABILITY, POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES, DIMINUTION IN EARNING CAPACITY, LOST WAGES, MEDICAL MONITORING EXPENSES, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, METALLOSIS, DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP). (B)(6). UPDATE 09/07/2011 - PLAINTIFF'S FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION. UPDATE 22 OCT 2014 - DER RCVD. ASR REVISION REPORTED VIA SALES REP. ASR XL. CONFIRMATION RECEIVED THAT THIS IS ACTUALLY THE LEFT SIDE NOT RIGHT AS PREVIOUSLY REPORTED. ASR REMOVAL AND REVISION. THE CORAIL STEM WAS LEFT IN PLACE WHILE THE ASR CUP & HEAD WAS REMOVED AND A MULTIHOLE GRIPTON CUP WITH 60 X 40 ATRX LINER INSERTED. UPDATED ADDITIONAL SURGEON, SALES REP INFO AND DOR.

    Description of Event or Problem · 1

    UPDATE REC'D 10/6/2014 ADDITIONAL INFORMATION RECEIVED FROM SALES REP. PATIENT WAS REVISED TO ADDRESS PAIN, LOOSENING AND ELEVATED METAL ION LEVELS. THE SLEEVE AND STEM ARE BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL 2445720

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R