BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN ASR FEMORAL HEAD

    MDR report key: 3191276 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19927
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289983 UKNOWN ASR FEMORAL HEAD TOTAL HIP REPLACEMENT KWA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other