BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERALIZD HUM CUP DIA 36+3MM

    MDR report key: 1120685 · Received August 14, 2008

    Report

    Report Number
    1818910-2008-03137
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    PMA / PMN Number
    K050315
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 BECAUSE OF PAIN WITH POSSIBLE NOTCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATERALIZD HUM CUP DIA 36+3MM 87KWS KWS DEPUY FRANCE S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention