BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI KNEE SYSTEM

    MDR report key: 5885356 · Received August 18, 2016

    Report

    Report Number
    0009617840-2016-00013
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    December 10, 2014
    Report Date
    December 15, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF MALFUNCTION OR FIT WITH THE PSI GUIDES, AND THE SURGEON STATED THAT THE NOTCHING MAY HAVE BEEN RELATED TO HIS USE OF A NEW TYPE OF SAW BLADE. DEVICE PRODUCT CODE OOG. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON STATED AFTER CUTTING THE FEMUR, THE PATIENT HAD A 2-3 MM NOTCH ON THE ANTERIOR SURFACE. THE SURGEON HAD TO RE-CUT THE TIBIA THREE TIMES TO FIT A 10 MM POLY. AS A RESULT, THERE WAS A TEN MINUTE DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537762 PSI KNEE SYSTEM KNEE ARTHROPLASTY IMPLANTATION SYSTEM JWH ZIMMER CAS N/A THO7DDR51DH14US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention