BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 513406 · Received February 24, 2004

    Report

    Report Number
    MW4003689
    Event Type
    Malfunction
    Date Received
    February 24, 2004
    Date of Event
    April 28, 2003
    Report Date
    January 7, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    KWT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WITH STATUS POST LEFT SHOULDER TOTAL ARTHROPLASTY IN 2002. PT HAD DONE WELL WITH THIS SURGERY UNTIL 2003. PT DESCRIBES ACTIVE MOTION OF SLIGHT ABDUCTION WHEN PT HEARD A SNAP IN THEIR SHOULDER FOLLOWED BY CONSIDERABLE PAIN. PT WAS SEEN AND TREATED FOR PAIN AT THE LOCAL HOSPITAL. SUBSEQUENTLY, PT WAS SEEN BY DR WITH QUESTIONABLE ROTATOR CUFF INJURY WITH LOOSE FRAGMENTS. IN FOLLOWUP THREE WEEKS LATER PT DEMONSTRATED THE GLENOID PROSTHESIS TO BE COMPLETELY DISLOCATED FROM THE GLENOID FOSSA. PROSTHESIS NOTED TO BE IN ANTERIOR ASPECT OF SHOULDER. ADMITTED FOR REMOVAL OF GLENOID PROSTHESIS LEFT SHOULDER. IN 2003 OPERATIVE PROCEDURE: REMOVAL OF LOOSE GLENOID COMPONENT AND CEMENT FROM THE GLENOID. AUTOGRAFT BONE GRAFTING OF THE GLENOID AND REPLACEMENT OF A LARGER HUMERAL HEAD COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET PALCOS CEMENT KWT BIOMET, INC. 424800 218-9608
    2 BIOMET GLENOID KWS * 113851 502330
    3 BIOMET HUMERAL KWS * 11-113708 855170
    4 BIOMET HEAD-OFFSET KWS * 113924 159810

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR