BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 509589 · Received February 2, 2004

    Report

    Report Number
    509589
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    December 19, 2003
    Report Date
    January 14, 2004
    Manufacturer
    BIOMET
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINS OF RIGHT SHOULDER PAIN WITH ALL RANGE OF MOTION. MILD EDEMA. TENDERNESS TO PALPATION OVER THE RIGHT SHOULDER JOINT. PAIN WITH EXTERNAL ROTATION. THE PT WAS ADMITTED FOR REVISION OF RIGHT TOTAL SHOULDER ARTHROPLASTY. THE CUP, LINER AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS TOTAL SHOULDER COMPONENTS/ABSOLUTE BI-POLAR SHOULDER MODULAR KWS BIOMET * 549580
    2 BIOMET ORTHOPEDICS BI-ANGULAR/BI-POLAR SHOULDER MODULAR HEAD KWT BIOMET * 582510
    3 BIOMET ORTHOPEDICS ABSOLUTE BI-POLAR SHOULDER SHELL W/ LOCKING RING MJT BIOMET * 687690
    4 BIOMET ORTHOPEDICS BI-AGULAR SHOULDER POROUS COATED KWT BIOMET * 157330

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R