BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ASR HIP

    MDR report key: 1870338 · Received October 11, 2010

    Report

    Report Number
    1818910-2010-07621
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    June 17, 2010
    Report Date
    September 30, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN
    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

    LEGAL CLAIM ALLEGES THE PT WAS REVISED TO ADDRESS FAILURE OF THE HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY ASR HIP TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention