BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2241728 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17639
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    January 2, 2014
    Report Date
    March 14, 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
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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.

    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** (B)(4) 2013 NEW LITIGATION PAPERS RECEIVED. MIDDLE INITIAL CHANGED TO (B)(6).

    Description of Event or Problem · 1

    UPDATE 03/14/2014 - PFS & MEDICAL RECORDS WERE OBTAINED. DOI WILL BE UPDATED. DOR WAS IDENTIFIED. PART/LOT INFORMATION FOR THE ACETABULAR CUP AND FEMORAL HEAD WERE PROVIDED BY THE PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. COMPLAINT WAS UPDATED ON 03/20/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2643474

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other