BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE TKA GUIDE/MODEL SET 04-05

    MDR report key: 2933404 · Received January 29, 2013

    Report

    Report Number
    0001825034-2013-00159
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK102795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. SUPPLIER MANUFACTURER CONFIRMED REPORTED EVENT. IT WAS DISCOVERED THAT THE QUALITY ENGINEER UPDATED THE PATIENT'S DATE OF BIRTH INFORMATION BASED ON WHAT WAS RECEIVED FROM THE IMAGING CENTER. THE IMAGING CENTER PROVIDED THE INCORRECT DATE OF BIRTH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 UTILIZING A SIGNATURE KNEE GUIDE. AFTER THE GUIDE WAS OPENED, IT WAS NOTICED THE GUIDE WAS MARKED WITH THE WRONG PATIENT DATE OF BIRTH. TRADITIONAL INSTRUMENTATION WAS USED TO FINISH THE PROCEDURE. AS A RESULT, A GREATER THAT THIRTY (30) MINUTE DELAY IN PROCEDURE WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39471 SIGNATURE TKA GUIDE/MODEL SET 04-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 066839

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R