BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET 16X22 RADIAL HEAD IMPLANT

    MDR report key: 1624757 · Received March 4, 2010

    Report

    Report Number
    MW5015026
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 24, 2010
    Manufacturer
    BIOMET
    Product Code
    JDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RADIAL HEAD INDICATED UNCOUPLED FROM THE IMPLANT STEM. IT WAS ALSO INDICATED THAT THE LOCKING SCREW HAD POSSIBLY LOOSENED. BOTH THE HEAD AND THE SCREW WERE IMPLANTED (B) (6) 2009 ON AN EXISTING STEM IMPLANTED (B) (6) 2008 (THESE WERE REPLACEMENTS FOR THE HEAD AND SCREW ORIGINALLY IMPLANTED WITH THE STEM ON (B) (6) 2008). STEM LOT# 091660, MFR # (B) (4), REPLACEMENT LOCKING SCREW LOT# 174710, MFR # (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET 16X22 RADIAL HEAD IMPLANT ELBOW IMPLANT JDC BIOMET 404590

    Patients

    Seq Age Sex Outcome Treatment
    1