BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2901565 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00039
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 9, 2010
    Report Date
    August 21, 2012
    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
    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. REF. (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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED THAT ALLEGE THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT WHICH HAS NEGATIVELY AFFECTED THEIR MOBILITY AND ABILITY TO PERFORM DAILY ACTIVITIES AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8568 ASR UNI FEMORAL IMPL SIZE 47 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2507916

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention