BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN RANAWAT-BURNSTEIN

    MDR report key: 6090498 · Received November 9, 2016

    Report

    Report Number
    0001825034-2016-04574
    Event Type
    Death
    Date Received
    November 9, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    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 PATIENT MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY VIJAY J. RASQUINHA, MD, CHITRANJAN S. RANAWAT, MD, VIPUL DUA, MD, AMAR S. RANAWAT, MD, AND JOSE A. RODRIGUEZ, MD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND STUDY OF SMOOTH VERSUS ROUGH STEMS USING CEMENT FIXATION," WHICH AIMED TO EVALUATE THE EFFECT OF SURFACE FINISH OF THE CEMENTED STEM IN PRIMARY HIP ARTHROPLASTIES. THE STUDY INCLUDED 244 HIPS (IN 237 PATIENTS) IMPLANTED BETWEEN JANUARY 1996 AND MAY 1997 BY A SINGLE SURGEON. THE STUDY FOUND NO SIGNIFICANT DIFFERENCE BETWEEN THE ROUGH AND SMOOTH SURFACED HIP STEMS USED. NINE PATIENTS (11 HIPS) WERE IDENTIFIED IN THE ARTICLE WHO WERE IMPLANTED WITH ROUGH HIP STEMS EXPIRED OR WERE LOST TO FOLLOW UP. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOMES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739909 UNKNOWN RANAWAT-BURNSTEIN PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death