BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS PSI KNEE SYSTEM

    MDR report key: 5885361 · Received August 18, 2016

    Report

    Report Number
    0009617840-2016-00028
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    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. PRODUCT CODE OOG. THIS MDR REPORTABLE EVENT WAS IDENTIFIED TO MEET REPORTING REQUIREMENTS OF 21 CFR 803 DURING AN INTERNAL REVIEW AND, THEREFORE, IS BEING FILED RETROSPECTIVELY. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER THE SUBMISSION OF THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PSI GUIDES WERE USED THROUGHOUT THE SURGERY AND THE TIBIAL PSI GUIDE FIT VERY WELL. THE TIBIAL GUIDE WAS PUT INTO PLACE AND THE SUBSEQUENT TIBIAL CUTTING HEAD WAS PINNED AND THE CUT WAS MADE. WHEN TRIALING THE KNEE FOR FLEXION, THE SURGEON WAS UNABLE TO FLEX THE KNEE MORE THAN 70 OR 80 DEGREES. THE FEMUR WAS DOWNSIZED FROM A 12 TO A 10 AND THE SURGEON STILL COULD NOT ACHIEVE ENOUGH FLEXION. THE TIBIAL CUT WAS ASSESSED AND WAS FOUND TO BE MADE WITH ANTERIOR SLOP. AN EXTRA MEDULLARY TIBIAL JIG WAS PUT INTO PLACE TO CORRECT THE SLOPE. ONCE CORRECTED, THE MAXIMUM 20MM POLY IMPLANT WAS NOT THICK ENOUGH, AND A NEXGEN TIBIA/AUGMENTS/STEM EXTENSION WAS NEEDED. THE PATIENT WAS ON THE OPERATING TABLE FOR AN EXTRA 1.5 HOURS WHILE NECESSARY TRAYS TO COMPLETE THE PROCEDURE WERE PICKED UP AND STERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538807 CAS PSI KNEE SYSTEM KNEE ARTHROPLASTY IMPLANTATION SYSTEM JWH ZIMMER CAS N/A MSU575R51RT14US

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other