BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL IMPLANT DISCOVERY

    MDR report key: 2202664 · Received August 4, 2011

    Report

    Report Number
    2202664
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BIOMET
    Product Code
    JDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT SUSTAINED A DISTAL HUMERUS TRANSCONDYLAR FRACTURE WITH A SHEAR FRACTURE OF THE TROCHLEA AND THE CAPITELLUM AS A RESULT OF A FALL. SHE UNDERWENT A TOTAL ELBOW REPLACEMENT IN JUNE USING THE DISCOVERY TOTAL ELBOW SYSTEM FROM BIOMET ORTHOPEDICS. PT STATES THAT SHE CONTINUES TO HAVE PAIN OF THE ELBOW WITH MOTION AS WELL AS SOME BURNING TYPE PAIN ON THE POSTERIOR ASPECT OF THE ELBOW. INFECTION HAS BEEN RULED OUT.IN MAY AN XRAY REPORT SHOWED NEW RADIOLUCENCY ADJOINING THE PROXIMAL HUMERAL COMPONENT OF THE LEFT ELBOW PROSTHESIS CONSISTENT WITH LOOSENING.IN JULY THE PATIENT RETURNED TO SURGERY FOR REMOVAL OF THE HUMERAL COMPONENT AND BONE CEMENT DUE TO LOOSENING. A LONGER SHAFT HUMERAL IMPLANT WAS PLACED. INTRAOPERATIVELY A SIGNIFICANT AMOUNT OF METALLOSIS WAS NOTED AS WAS GRANULATION TISSUE WHICH WAS THOROUGHLY DEBRIDED AND REMOVED. PATIENT DISCHARGED 3 DAYS LATER WITH FOLLOWUP IN APPROX 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL IMPLANT DISCOVERY HUMERAL IMPLANT JDC BIOMET 114904 278490
    2 HUMERAL CONDYLE KIT DISCOVERY HUMERAL CONDYLE JDC BIOMET 114700 632520
    3 BONE CEMENT COBALT BONE CEMENT LOD BIOMET 402439 738280
    4 CEMENT PLUG 10MM BONE CEMENT PLUG LOD BIOMET 41994 007530

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R