BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MODULAR HEAD -3MM

    MDR report key: 4812284 · Received June 2, 2015

    Report

    Report Number
    0001825034-2015-02377
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 7, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND WAS IMPLANTED WITH COMPETITOR PRODUCTS. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2006 DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, A BIOMET FEMORAL STEM AND MODULAR HEAD WERE IMPLANTED. PATIENT WAS REVISED AGAIN ON (B)(6) 2015 DUE TO CHRONIC DISLOCATION. THE BIOMET HEAD AND COMPETITOR ACETABULAR LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357134 36MM COCR MODULAR HEAD -3MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 619180

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R