BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANAT BEARING RT LG SIZE 3 PMA

    MDR report key: 4261012 · Received November 19, 2014

    Report

    Report Number
    0001825034-2014-08691
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 9, 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
    WI, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2014 DUE TO INFECTION. THE TIBIAL BEARING WAS REPLACED AND AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749329 OXFORD ANAT BEARING RT LG SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R