BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3221571 · Received July 11, 2013

    Report

    Report Number
    1818910-2013-21009
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    September 16, 2011
    Report Date
    June 12, 2013
    Manufacturer
    DEPUY INTL., LTD. ? REG. # 8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    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 ALLEGED: FREQUENT AND SIGNIFICANT PAIN IN HER RIGHT HIP. DOI: (B)(6) 2009 RIGHT HIP. DOR: NONE REPORTED. PATIENT RESIDENCE: (B)(6). UPDATE: (B)(6) 2012 - ADDITIONAL INFORMATION HAS BEEN RECEIVED. REPORT STATES: IT IS ALLEGED THAT SINCE THE SURGERY THE PATIENT HAS EXPERIENCED PAIN CAUSED BY FAILURE OF THE SYSTEM INCLUDING BUT NOT LIMITED TO: LOOSENING OF THE COMPONENTS AND THE GENERATION OF EXCESSIVE METALLIC DEBRIS DURING NORMAL USE. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THIS INVESTIGATION. REVISION SURGERY HAS YET TO BE REPORTED. UPDATE ((B)(6) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED, AND A PRODUCT HAS BEEN ADDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOR: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319824 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. ? REG. # 8010379 2859540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention