BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2915166 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-01108
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    August 23, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    (B)(4). DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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, STIFFNESS, EXCESSIVE LEVELS OF CHROMIUM AND COBALT, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTS THE PATIENT'S MOBILITY AND QUALITY OF LIFE.

    Description of Event or Problem · 1

    UPDATE REC'D 11/17/2016 AMENDED SUPPLEMENTAL. PATIENT WAS REVISED (B)(6) 2015. ADDING THE TAPER SLEEVE AND FEMORAL STEM FOR THE ELEVATED IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22138 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2452395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other