BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD/COCR

    MDR report key: 1062035 · Received June 6, 2008

    Report

    Report Number
    1825034-2008-00168
    Event Type
    Injury
    Date Received
    June 6, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 12, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE DID NOT IDENTIFY ANY ABNORMALITY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. USER FACILITY REPORT STATES THAT DEVICE IS AVAILABLE FOR EVAL. USER FACILITY WAS CONTACTED IN AN EFFORT TO OBTAIN THE DEVICE. TO DATE, DEVICE HAS NOT BEEN RETURNED TO BIOMET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT BI-POLAR ARTHROPLASTY PROCEDURE IN 2007. THE PT FELL AND DISLOCATED THE HIP. DURING AN ATTEMPT TO REDUCE THE HIP, THE MODULAR HEAD COMPONENT DISASSOCIATED FROM THE BI-POLAR CUP COMPONENT. PT UNDERWENT BI-POLAR HIP REVISION PROCEDURE IN 2008

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD/COCR PROSTHESIS, HIP COMPONENT JDI BIOMET, INC. NA 363990

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R