BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT XL SIZE 3 PMA

    MDR report key: 3932639 · Received July 14, 2014

    Report

    Report Number
    0001825034-2014-06148
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 21, 2014
    Report Date
    March 4, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    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 DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 20 STATES: "PERSISTENT PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PARTIAL RIGHT KNEE ARTHROPLASTY ON (B)(6), 2014. SUBSEQUENTLY, AN IRRIGATION AND DEBRIDEMENT PROCEDURE WAS PERFORMED ON (B)(6), 2014 DUE TO PAIN AND INFLAMMATION. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409741 OXF ANAT BRG RT XL SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2648193

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R