BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PSI KNEE SYSTEM

    MDR report key: 3835032 · Received March 25, 2014

    Report

    Report Number
    9617840-2014-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ZIMMER CAS,
    Product Code
    JWH
    PMA / PMN Number
    K131409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING AND X-RAYS HAVE BEEN REQUESTED TO ALLOW ASSESSING THE NOTED PERFORMANCE DEPARTURES AND WHETHER THEY ARE ON OF SPECIFICATION AND COULD CAUSE PT INJURY. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INFO IS AVAILABLE.

    Description of Event or Problem · 1

    AFTER USING THE FEMORAL PT SPECIFIC INSTRUMENT (PSI) GUIDE COMPONENT OF THE ZIMMER PSI KNEE SYSTEM DURING A TOTAL KNEE REPLACEMENT SURGERY TO POSITION THE FEMORAL CUTTING GUIDE OF THE IMPLANT SYSTEM, THE SURGEON NOTED AFTER THE FEMORAL CUTS WERE COMPLETED THAT THERE WAS A SLIGHT ANTERIOR NOTCH (REPORTED AT 2 MM) WHERE THE ANTERIOR CUT EXITS THE ANTERIOR CORTEX, AND THAT THE POSTERIOR RESECTIONS WERE LESS THAN NORMALLY EXPECTED (EXTENT OF DEPARTURE NOT REPORTED). THE SURGEON DID NOT PERFORM ANY CORRECTIONS AND THERE WAS NO REPORTED REMAINING PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173764 ZIMMER PSI KNEE SYSTEM TOTAL KNEE REPLACEMENT INSTRUMENTS JWH ZIMMER CAS, 20-8070-005-02 A140095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other