BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RINGLOC LINER 10DEG

    MDR report key: 1884337 · Received October 27, 2010

    Report

    Report Number
    1825034-2010-00473
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K926107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED.CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE.EXP. DATE - COULD NOT BE DETERMINED SINCE NO LOT NUMBER WAS PROVIDED.MANUFACTURING DATE - COULD NOT BE DETERMINED SINCE NO LOT NUMBER WAS PROVIDED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REVISION ON (B)(6), 1995. SUBSEQUENTLY, THE PATIENT WAS REVISED (B)(6), 2010, DUE TO DISLOCATION AND METALOSIS AROUND THE TROCHANTERIC REGION. THE TROCHANTERIC BOLT, MODULAR HEAD, AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCOM 28MM RINGLOC LINER 10DEG PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R