BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6086709 · Received November 8, 2016

    Report

    Report Number
    0001825034-2016-04544
    Event Type
    Injury
    Date Received
    November 8, 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
    NL
    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. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY WIERD P. ZIJLSTRA, HUGO C. VAN DER VEEN, INGE VAN DEN AKKER-SCHEEK, MARK J. M. ZEE, SJOERD K. BULSTRA AND JOS J. A. M. VAN RAAY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON THE JOURNAL ARTICLE, ¿ACETABULAR BONE DENSITY AND METAL IONS AFTER METAL-ON-METAL VERSUS METAL-ON-POLYETHYLENE TOTAL HIP ARTHROPLASTY; SHORT-TERM RESULTS." THE AIM OF THE PRESENT STUDY WAS TO SET UP A RANDOMISED CLINICAL TRIAL TO EVALUATE PERIPROSTHETIC ACETABULAR BONE DENSITY AND SERUM METAL ION LEVELS IN MOM CEMENTLESS THA, COMPARED TO MOP CEMENTLESS THA. THE STUDY INCLUDED PATIENTS EXPERIENCING NON-INFLAMMATORY DEGENERATIVE HIP JOINT DISEASE INCLUDING OSTEOARTHRITIS, AVASCULAR NECROSIS AND TRAUMATIC ARTHRITIS, AGED BETWEEN 45 AND 75 YEARS. TWO PATIENTS WITH METAL-ON-POLY IMPLANTS WERE IDENTIFIED IN THE ARTICLE, WHO EXHIBITED EVIDENCE OF BONE RESORPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737567 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other