BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2541278 · Received April 13, 2012

    Report

    Report Number
    2541278
    Date Received
    April 13, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 12, 2012
    Manufacturer
    BIOMET INC
    Product Code
    JDI
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION OF TOTAL HIP REPLACEMENT IN 2008. INITIALLY HE DID WELL, BUT LATELY HAS HAD INCREASING PAIN OVER THE PAST SEVERAL MONTHS STARTING ABOUT THANKSGIVING TIME. PAIN FAILED TO RESOLVE DESPITE USE OF ANTI-INFLAMMATORIES REGULARLY AND CAIN USE, AND HAS RESULTED IN SIGNIFICANT LIMP. HE APPEARS TO HAVE LOOSENING OF HIS ACETABULAR SIDE AND HAS CONSENTED FOR ANOTHER REVISION SURGERY. THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY REVISION ACETABULAR AND FEMORAL HEAD COMPONENT. NO COMPLICATIONS WERE NOTED. THE FOLLOWING IS AN EXCERPT FROM PATHOLOGY. 1. TOTAL HIP ARTHROPLASTY REVISION ACETABULAR AND FEMORAL HEAD COMPONENT TOTAL HIP ARTHROPLASTY REVISION ACETABULAR AND FEMORAL HEAD COMPONENT. 2. ORTHOPEDIC HARDWARE- THERE IS GREENISH CEMENT MATERIAL ON THE OUTSIDE OF THE ACETABULAR PORTION OF THE SPECIMEN. THIS PORTION OF THE HARDWARE MEASURES UP TO 4.8 CM IN DIAMETER AND IS MARKED WITH THE NUMBER B 42X4AMM 230580. THE ROUNDED SMOOTH SHINY PORTION OF THE JOINT HARDWARE MEASURES UP TO 3.8 CM IN DIAMETER. ON THE LOWER ASPECT THERE IS A MARKING THAT IS +3 AND ALSO THE NUMBER 42. THE PATIENT DID WELL AND WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ORTHOPEDIC IMPLANT JDI BIOMET INC * 058090

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR