BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS PSI KNEE SYSTEM

    MDR report key: 5885377 · Received August 18, 2016

    Report

    Report Number
    0009617840-2016-00023
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    May 1, 2015
    Report Date
    May 1, 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
    NY, 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. DEVICE PRODUCT CODE: OOG. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL KNEE ARTHROPLASTY THERE WAS SEVERE ANTERIOR FEMUR NOTCHING WHILE USING THE PSI INSTRUMENTATION. THE SURGEON HAD PLACED THE DEVICE IN HYPEREXTENSION AND NOTCHING OCCURRED 5-10 MM ABOVE ANTERIOR FLANGE. IT WAS STATED BY THE SURGEON TO BE THEIR POSITION OF THE DEVICE THAT LED TO THE NOTCHING. AS A RESULT THERE WAS A 15 MINUTE DELAY. THE PROCEDURE WAS COMPLETED WITH STANDARD INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539627 CAS PSI KNEE SYSTEM KNEE ARTHROPLASTY IMPLANTATION SYSTEM JWH ZIMMER CAS N/A JHA5C2L43TC15US

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention