BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERALIZD HUM CUP IDA 36+9MM

    MDR report key: 729928 · Received June 23, 2006

    Report

    Report Number
    1818910-2006-01728
    Event Type
    Injury
    Date Received
    June 23, 2006
    Date of Event
    May 31, 2006
    Report Date
    May 31, 2006
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PHYSICIAN

    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

    PT WAS REVISED, DUE TO DISLOCATION AND POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATERALIZD HUM CUP IDA 36+9MM TOTAL SHOULDER REPLACEMENT KWS DEPUY FRANCE S.A. NA 1890659

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention