BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4901338 · Received July 9, 2015

    Report

    Report Number
    0001825034-2015-02879
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS INFORMATION WAS ORIGINALLY REPORTED ON 1825034-2015-02952 WHICH REFERENCED A JOURNAL ARTICLE WRITTEN ON A STUDY THAT THIS PATIENT TOOK PART IN.

    Description of Event or Problem · 1

    PATIENT WAS LISTED AS TAKING PART OF THE STUDY IN A JOURNAL ARTICLE TITLED, "A SECOND DECADE LIFETABLE SURVIVAL ANALYSIS OF THE OXFORD UNICOMPARTMENTAL KNEE ARTHROPLASTY". IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447509 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R