BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP

    MDR report key: 6083936 · Received November 7, 2016

    Report

    Report Number
    0001825034-2016-04486
    Event Type
    Death
    Date Received
    November 7, 2016
    Report Date
    October 11, 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
    NY, 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 WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON THE JOURNAL ARTICLE, ¿FIXATION AND OSTEOLYSIS IN PLASMA-SPRAYED HEMISPHERICAL CUPS WITH HYBRID TOTAL HIP ARTHROPLASTY." THE AIM OF THE ARTICLE IS TO ANALYZE DATA RETRIEVED FIVE TO TWELVE YEARS POST-IMPLANTATION FOR PRIMARY HYBRID TOTAL HIP ARTHROPLASTY USING S PLASMA-SPRAYED HEMISPHERICAL CUP. TWO HUNDRED THIRTEEN SELECTED PATIENTS UNDERWENT PRIMARY HYBRID THA BY THE SENIOR AUTHOR. SELECTION CRITERIA INCLUDED 3 VARIABLES: WEIGHT LESS THAN 180 LB., AGE LESS THAN 65 YEARS, AND A CORTICAL INDEX EQUAL TO OR LOWER THAN 38%. THE AVERAGE FOLLOW-UP PERIOD FOR THE STUDY WAS 8.5 YEARS. TEN PATIENTS IDENTIFIED IN THE ARTICLE EXPIRED BEFORE THE FIVE YEAR FOLLOW-UP DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734603 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death