BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2942670 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-02080
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    October 15, 2012
    Report Date
    August 30, 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 Occupation
    PATIENT

    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).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN AND DISABILITY. IN ADDITION, THE PATIENT HAS BEEN EXPOSED TO CHROMIUM AND COBALT AS A RESULT OF THE ASR IMPLANT AND HAS BEEN DAMAGED PHYSICALLY FROM SAID EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46999 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2709308

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention