BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP

    MDR report key: 5940947 · Received September 9, 2016

    Report

    Report Number
    3002806535-2016-00717
    Event Type
    Death
    Date Received
    September 9, 2016
    Report Date
    August 11, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY C. INNGUL, R. BLOMFELDT, S. PONZER, AND A. ENOCSON. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, ¿CEMENTED VERSUS UNCEMENTED ARTHROPLASTY IN PATIENTS WITH A DISPLACED FRACTURE OF THE FEMORAL NECK,¿ WHICH AIMED COMPARE THE FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF AN UNCEMENTED HYDROXYAPATITE-COATED STEM WITH A CEMENTED STEM, IN PATIENTS UNDERGOING SURGERY FOR A DISPLACED FRACTURE OF THE FEMORAL NECK. FOUR PATIENTS IDENTIFIED IN THE ARTICLE EXPIRED WITHIN TWELVE MONTHS OF INITIAL TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590576 UNKNOWN HIP PROSTHESIS, HIP LPH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death