BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM +3

    MDR report key: 3599068 · Received January 30, 2014

    Report

    Report Number
    0001825034-2014-00572
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    May 7, 2008
    Report Date
    September 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00572-1 / 00573-1 / 03480-1).

    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 2) EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00572 & 00573).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2008 DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS COMPLETED AND THE ACETABULAR LINER AND MODULAR HEAD WERE REPLACED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66417 SELEX/MAGNUM MODULAR HEAD 40MM +3 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 306190

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R