BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BRG RT LG SIZE 8

    MDR report key: 3797178 · Received May 7, 2014

    Report

    Report Number
    0001825034-2014-03638
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    August 29, 2013
    Report Date
    March 7, 2016
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR ASSOCIATED DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013. THE BEARING WAS REMOVED AND REPLACED WITH A LARGER BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274166 OXF ANATOMIC BRG RT LG SIZE 8 PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 2742447

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R