BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS PSI KNEE SYSTEM

    MDR report key: 5885372 · Received August 18, 2016

    Report

    Report Number
    0009617840-2016-00019
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    ZIMMER CAS
    Product Code
    JWH
    PMA / PMN Number
    PK131409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DEVICE PRODUCT CODE - OOG. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON USED THE RESECTION GUIDE ON THE 4IN1 BLOCK. AFTER THE RESECTION, SURGEON NOTED NOTCHING ON THE FEMUR IN EXTENSION. AS A RESULT THE SURGEON DRILLED UP THE CANAL TO CLEAN UP THE DISTAL CUT AND DOWNSIZED THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537516 CAS PSI KNEE SYSTEM KNEE ARTHROPLASTY IMPLANTATION SYSTEM JWH ZIMMER CAS N/A BLO737R51ST15US

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention