BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD LEFT MEDIAL TIBIAL TRAY STANDARD SIZE E

    MDR report key: 1844337 · Received September 24, 2010

    Report

    Report Number
    1825034-2010-00392
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    April 28, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE - OCTOBER 2008.CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR.(B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO OPERATIVE REPORTS RECEIVED FROM BIOMET'S LEGAL DEPARTMENT, PATIENT UNDERWENT OXFORD PARTIAL KNEE PROCEDURE ON (B)(6) 2009. BIOMET'S INVOICE HISTORY REFLECTS REVISION OF THE POLYETHYLENE COMPONENT ON (B)(6) 2010. HOWEVER, BIOMET HAS NOT RECEIVED THAT PARTICULAR OPERATIVE REPORT AND, THEREFORE, RECORDS ARE INCOMPLETE AT THIS TIME. AN OPERATIVE REPORT DATED (B)(6) 2010, STATES THAT PATIENT WAS REVISED TO A TOTAL KNEE DUE TO RECURRENT DISLOCATED POLYETHYLENE.

    Description of Event or Problem · 1

    ACCORDING TO OPERATIVE REPORTS RECEIVED FROM BIOMET'S LEGAL DEPARTMENT, PATIENT UNDERWENT OXFORD PARTIAL KNEE PROCEDURE ON (B)(6), 2009. BIOMET'S INVOICE HISTORY REFLECTS REVISION OF THE POLYETHELENE COMPONENT ON (B)(6), 2010. HOWEVER, BIOMET HAS NOT RECEIVED THAT PARTICULAR OPERATIVE REPORT AND, THEREFORE, RECORDS ARE INCOMPLETE AT THIS TIME. AN OPERATIVE REPORT DATED APRIL 28, 2010, STATES THAT PATIENT WAS REVISED TO A TOTAL KNEE DUE TO RECURRENT DISLOCATED POLYETHELENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD LEFT MEDIAL TIBIAL TRAY STANDARD SIZE E PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 600988

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R