BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD OBLONG TROCHANTER BOLT

    MDR report key: 2080664 · Received May 6, 2011

    Report

    Report Number
    1825034-2011-00355
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K031693
    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP ARTHROPLASTY ON (B)(6) 2011 FOR AN UNKNOWN REASON. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AS PART OF A TWO STAGE REVISION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY/HEAD OBLONG TROCHANTER BOLT PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 584060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R