BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP

    MDR report key: 5880567 · Received August 16, 2016

    Report

    Report Number
    0001825034-2016-03097
    Event Type
    Death
    Date Received
    August 16, 2016
    Report Date
    July 18, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY A. V. LOMBARDI JR, K. R. BEREND, M. J. MORRIS, J. B. ADAMS, AND M. A. SNELLER. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "LARGE-DIAMETER METAL-ON-METAL TOTAL HIP ARTHROPLASTY: DISLOCATION INFREQUENT BUT SURVIVORSHIP POOR" WHICH AIMED TO DETERMINE AT A MINIMUM OF 2 YEARS¿ FOLLOWUP (1) THE PROPORTION OF PATIENTS WHO EXPERIENCED A DISLOCATION; (2) THE SHORT-TERM SURVIVORSHIP OBTAINED WITH THESE IMPLANTS; (3) THE CAUSES OF FAILURE AND THE PROPORTION OF PATIENTS WHO DEVELOPED ARMD; AND (4) WHETHER THERE WERE ANY IDENTIFIABLE RISK FACTORS FOR REVISION. IN THE ARTICLE, FIFTY-ONE PATIENTS WERE IDENTIFIED AS HAVING EXPIRED DUE TO UNKNOWN REASONS DURING THE FIRST TWO YEARS OF THE STUDY PERIOD. NONE OF THE PATIENTS HAD UNDERGONE REVISION PROCEDURES AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532877 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death