BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER SLEEVE ADAPTER 12/14 +8

    MDR report key: 1960913 · Received January 11, 2011

    Report

    Report Number
    1818910-2011-00276
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 12, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING AND METALOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPER SLEEVE ADAPTER 12/14 +8 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1221332

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention