BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 28MM HEAD DIAMETER

    MDR report key: 2081722 · Received May 9, 2011

    Report

    Report Number
    1825034-2011-00358
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K911684
    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. 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 EIGHT STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." THIS REPORT SUBMITTED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO A DISLOCATION CAUSED BY A FALL. THE MODULAR HEAD, ACETABULAR CUP, AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD COMPONENT 28MM HEAD DIAMETER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 337810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R