BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SHOULDER JOINT REPLACEMENT PROSTHESES

    MDR report key: 1981130 · Received February 3, 2011

    Report

    Report Number
    1981130
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 25, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT IS A (B)(6) YEAR OLD MALE WITH A HISTORY OF ADVANCED ARTHRITIS IN THE RIGHT SHOULDER. ON (B)(6) 2009, THE PT HAD A RIGHT SHOULDER HEMIARTHROPLASTY USING A BIOMET STEM. HE DID WELL UNTIL THE FALL OF 2010 WHEN HE WAS REMOVING A COMPUTER FROM A CAR AND FELT A POP IN THE RIGHT SHOULDER. ON (B)(6) 2010, HE UNDERWENT A SECOND RIGHT SHOULDER SURGERY THAT INVOLVED A REVERSE TOTAL SHOULDER REPLACEMENT UN-CEMENTED. DURING THAT PROCEDURE, THE EXISTING HUMERAL STEM WAS REVISED TO ALLOW A BETTER ANGLE OF IMPACT TO IMPLANT THE GLENOSPHERE. THE PT'S FIRST POST-OP FOLLOW UP EXAMINATION WAS (B)(6) 2010. THE EXAMINATION REVEALED DISSOCIATION BETWEEN THE GLENOID BASE PLATE AND THE GLENOSPHERE. THE PT WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR REVISION. THE SURGEON INSPECTED THE HARDWARE AND NOTED THAT THE SCREWS WERE INTACT, WITH NO EVIDENCE OF SCREW LOOSENING, MALPOSITION, OR PLACEMENT ISSUES. THE EXISTING HARDWARE WAS NOT REPLACED AND THE ONLY CHANGE WAS TO INCREASE THE THICKNESS OF THE TRAY USING A POLYURETHANE PAD THAT AFFIXES TO THE TRAY. THE SURGEON FELT THAT USE OF THE PAD WAS NECESSARY TO IMPROVE STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SHOULDER JOINT REPLACEMENT PROSTHESES SHOULDER JOINT REPLACEMENT HARDWARE KWS BIOMET ORTHOPEDICS 115310/115330 818700/524510

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention