BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET, INC.

    MDR report key: 475450 · Received July 31, 2003

    Report

    Report Number
    475450
    Event Type
    Injury
    Date Received
    July 31, 2003
    Date of Event
    June 24, 2003
    Report Date
    July 30, 2003
    Manufacturer
    BIOMET, INC.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/9/03: IN RESPONSE TO REQUESTS 1,2, & 4, PLEASE REFER TO MEDWATCH REPORT 1825034-2003-00079. IN RESPONSE TO REQUEST #3, PLEASE SEE ATTACHED SPREAD SHEET WITH MANUFACTURING AND DISTRIBUTION NUMBERS.

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSPITAL FOLLOWING SHOULDER DISLOCATION AT HOME AFTER ROLLING OVER IN BED. X-RAYS REVEALED POSTERIOR DISLOCATION OF THE IMPLANTED HUMERAL HEAD THAT BECAME DISSOCIATED FROM THE STEM. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REVISION OF RIGHT TOTAL SHOULDER ARTHROPLASTY. FIRST TOTAL SHOULDER WAS PERFORMED IN 1995. THE PATIENT UNDERWENT A REVISION OF THIS IN 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET, INC. TOTAL SHOULDER IMPLANT KWS BIOMET, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention