BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC ACETABULAR LINER 40MM SZ 25

    MDR report key: 2103603 · Received May 26, 2011

    Report

    Report Number
    1825034-2011-00434
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K070364
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER EIGHT SAYS, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY." THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2011, IMPLANTING A BIOMET ORTHOPEDICS POLYETHYLENE LINER WITH ANOTHER MANUFACTURERS' MODULAR HEAD. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E1 RINGLOC ACETABULAR LINER 40MM SZ 25 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 569400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R