BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 5940526 · Received September 9, 2016

    Report

    Report Number
    0001825034-2016-03537
    Event Type
    Injury
    Date Received
    September 9, 2016
    Report Date
    August 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
    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 PATIENT MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY OLLE MUREN, EHSAN AKBARIAN, MATS SALEMYR, HENRIK BODÉN, THOMAS EISLER, ANDRÉ STARK, AND OLOF SKÖLDENBERG. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "NO EFFECT OF RISEDRONATE ON FEMORAL PERIPROSTHETIC BONE LOSS FOLLOWING TOTAL HIP ARTHROPLASTY," WHICH AIMED TO INVESTIGATE THE EFFECT OF RISEDRONATE THERAPY ON PERIPROSTHETIC BONE RESORPTION DURING THE FIRST 4 YEARS AFTER TOTAL HIP ARTHROPLASTY (THA). FIFTEEN PATIENTS IDENTIFIED IN THE ARTICLE HAD RADIOGRAPH EVALUATION SHOWING CLASS I-II HETEROTROPIC OSSIFICATION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593178 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other