BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 2167773 · Received July 13, 2011

    Report

    Report Number
    MW5021359
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) MALE WHO HAD RIGHT SHOULDER REVERSE TOTAL SHOULDER ARTHROPLASTY (B)(6) 2010. HE WAS DOING WELL PRIOR TO A RECENT FALL DIRECTLY POSTERIOR ONTO HIS SHOULDER. HE NOTED PAIN AND INSTABILITY WITH CREPITUS OF THE SHOULDER. HE WAS DIAGNOSED WITH A BROKEN TRUNNION. IT WAS FELT HIS BEST OPTION WAS A REVISION. HE WAS ADMITTED TO THE HOSPITAL FOR SURGERY AT WHICH TIME THE HUMERAL TRAY WAS FOUND TO BE FRACTURED, WAS REMOVED AND REPLACED. PT DID WELL AND WAS DISCHARGED HOME (B)(6) AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE HUMERAL TRAY HSD BIOMET ORTHOPEDICS 115340 788680

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R