BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANATOMIC BEARING

    MDR report key: 1173445 · Received September 25, 2008

    Report

    Report Number
    1825034-2008-00244
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT UNILATERAL KNEE PROCEDURE IN EARLY 2008. PATIENT RETURNED TO THE OR FOR REVISION OF PROCEDURE, EXCHANGE OF TIBIAL INSERT APPROX SIX MONTHS LATER. THE OXFORD MENISCAL BEARING COMPONENT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD ANATOMIC BEARING PROSTHESIS, KNEE COMPONENT NRA BIOMET INC. N/A 310731

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R