BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD FEMORAL COMPONENT

    MDR report key: 3623731 · Received February 12, 2014

    Report

    Report Number
    0001825034-2014-00794
    Event Type
    Injury
    Date Received
    February 12, 2014
    Report Date
    January 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "FRACTURE OF AN OXFORD FEMORAL COMPONENT: A CASE REPORT." ELSEVIER B.V. (OCTOBER 2012). 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN, EXPIRATION DATE - UNKNOWN, DATE IMPLANTED - UNKNOWN, DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY HUGO C. VAN DER VEEN AND JOS J.A.M. VAN RAAY. MANUFACTURE DATE ¿ UNKNOWN IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ON THE FRACTURE OF AN OXFORD FEMORAL COMPONENT: A CASE REPORT. IT WAS REPORTED PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY IN 2002. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO A FRACTURED FEMORAL COMPONENT. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92997 UNKNOWN OXFORD FEMORAL COMPONENT PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R