BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD/COCR

    MDR report key: 1000022 · Received January 18, 2008

    Report

    Report Number
    1825034-2008-00018
    Event Type
    Injury
    Date Received
    January 18, 2008
    Date of Event
    December 15, 2007
    Report Date
    December 21, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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. H6:EVALUATION OF RETURNED COMPONENTS WAS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT BI-POLAR HIP PROCEDURE IN 2007. SUBSEQUENTLY, MODULAR HEAD COMPONENT DISASSOCIATED AND LOOSENING OF THE STEM COMPONENT WAS NOTED DURING REVISION PROCEDURE ON ABOUT 15 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD/COCR JDI JDI BIOMET, INC. NA 933690

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L