BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR COMPONENTS

    MDR report key: 1983053 · Received February 4, 2011

    Report

    Report Number
    1818910-2011-01718
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 7, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    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

    CLASS ACTION LAWSUIT STATES THE PT WAS REVISED FOR PAIN AND SWELLING. UNK WHERE SURGERY TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR COMPONENTS 87 KWA KWA DEPUY INTL., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention