BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEEALIGN 2

    MDR report key: 12099232 · Received July 1, 2021

    Report

    Report Number
    3007521480-2021-00014
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    January 15, 2020
    Report Date
    June 29, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006336
    PMA / PMN Number
    K172462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE FEMORAL CUTTING BLOCK, DISTAL PADDLE, AND MICROBLOCK WAS PERFORMED. THE CUTTING BLOCK WAS ABLE TO BE ASSEMBLED TO THE RETURNED MICROBLOCK WITHOUT ANY ISSUE. THERE WERE NO ISSUES OBSERVED DURING A FIT CHECK OF ALL THREE MECHANICAL INSTRUMENTS. NO ISSUES WERE OBSERVED WITH THE DISTAL PADDLE. NO ISSUES WERE OBSERVED WITH THE MICROBLOCK. NO ISSUES WERE OBSERVED WITH THE FEMORAL CUTTING BLOCK. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF ALERT LIMITS ARE EXCEEDED. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF ALERT LIMITS ARE EXCEEDED. THIS INITIAL REPORT IS BEING FILED AFTER THE DUE DATE AS THE INITIAL SUBMISSION WAS FOUND TO HAVE NOT BE RECEIVED DURING AN ATTEMPT TO SUBMIT THE FOLLOW-UP REPORT. AT THAT TIME, THE ERROR MESSAGE "ERROR: INITIAL REPORT / PRIOR SUPPLEMENT HAS NOT BEEN RECEIVED. THE INITIAL REPORT IS MISSING." ALERTED ORTHALIGN INC OF THE ISSUE PROMPTING THE SUBMISSION OF THIS AS AN INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN. FEMORAL DISTAL CUT WAS SUPPOSED TO BE 9MM BUT THE FEMORAL BONE WAS ACTUALLY CUT ABOUT 15MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997819 KNEEALIGN 2 MICROBLOCK ASSEMBLY OLO ORTHALIGN, INC. 402042 12050101Z 00858704006336

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention