BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14/ +5

    MDR report key: 1040095 · Received May 7, 2008

    Report

    Report Number
    1818910-2008-01811
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    January 7, 2008
    Report Date
    January 7, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RESULT OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LATE ONSET HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14/ +5 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2177798

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention NA.