BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 32MM HEAD DIAMETER -3MM NECK

    MDR report key: 1873077 · Received October 18, 2010

    Report

    Report Number
    1825034-2010-00433
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K974558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. 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: DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, THE PATIENT SUFFERED HIP DISLOCATION AND A CLOSED REDUCTION PROCEDURE WAS PERFORMED ON (B)(6) 2010. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD COMPONENT 32MM HEAD DIAMETER -3MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 918780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R