BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SLEEVE

    MDR report key: 1945677 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10773
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 6, 2009
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K934412
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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 PT WAS REVISED BECAUSE OF METAL SENSITIVITY. STEM/SLEEVE WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SLEEVE TOTAL HIP REPLACEMENT KWY DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention