BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 5 PMA

    MDR report key: 3963510 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06513
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    March 7, 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
    KY, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION AND TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2014 DUE TO SUSPECTED INFECTION. DURING THE PROCEDURE, THE BEARING WAS REMOVED AND REPLACED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION PROCEDURE AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442003 OXF ANAT BRG LT MD SIZE 5 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 406360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R