BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANSWER 15X155 COCR LAT

    MDR report key: 3121811 · Received May 21, 2013

    Report

    Report Number
    0001825034-2013-01591
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDG
    PMA / PMN Number
    PK931194
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2012. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013 DUE TO LOOSENING OF THE STEM. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223529 ANSWER 15X155 COCR LAT PROSTHESIS, HIP JDG BIOMET ORTHOPEDICS N/A 223970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R