BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMIS IPD

    MDR report key: 563321 · Received December 30, 2004

    Report

    Report Number
    3004153240-2004-00003
    Event Type
    Injury
    Date Received
    December 30, 2004
    Date of Event
    December 4, 2004
    Report Date
    December 29, 2004
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED CONFORMIS IPD IN 2004 AND WAS DOING WELL UNTIL ABOUT THREE AND HALF WEEKS LATER WHEN PT SLIPPED AND TWISTED THEIR KNEE. THEY SAW THE DOCTOR FOUR DAYS LATER AT WHICH TIME THE DEVICE WAS FOUND TO BE DISLOCATED AND THE EVENT WAS REPORTED TO CONFORMIS, INC. THE PT IS ONE OF TWO WHO HAD RECEIVED THE WRONG DEVICE DUE TO AN ERROR DURING THE DESIGN OF THE DEVICES AND A MIX-UP OF THE TWO MRI IMAGES. (CAPA WAS INITIATED AND CORRECTIVE ACTION TAKEN). THE PT WAS RE-OPERATED AND THE CORRECT IPD DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFORMIS IPD KNEE INTERPOSITIONAL IMPLANT JWH CONFORMIS, INC. 1060-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention