BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 2621430 · Received June 13, 2012

    Report

    Report Number
    MW5025803
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    October 28, 2011
    Report Date
    June 13, 2012
    Manufacturer
    BIOMET
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD REVERSE SHOULDER ARTHROPLASTY IN 2009, PT CAME TO HOSPITAL FOR SHOULDER REVISION ARTHROPLASTY ON (B)(6) 2011. DEVICE FAILED AT THE CONNECTION OF THE HUMERAL HEAD AND CUP. HOSPITAL WAS NOTIFIED OF EVEN ON (B)(6) 2012. THE MANUFACTURER OF THE PROSTHESIS WAS BIOMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET COMPREHESIVE HSD BIOMET 072230

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention