BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TOTAL SHOULDER

    MDR report key: 515662 · Received March 12, 2004

    Report

    Report Number
    1818910-2004-00218
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    October 2, 2002
    Report Date
    March 2, 2004
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT RECEIVED AN ORTHOPAEDIC SHOULDER JOINT REPLACEMENT IN 1993. THE COMPLAINT ALLEGES THE JOINT FAILED, REQUIRING REVISION IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK TOTAL SHOULDER EXTREMITIES KWR DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention