BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER® PATIENT SPECIFIC INSTRUMENT

    MDR report key: 5070400 · Received September 11, 2015

    Report

    Report Number
    3005718816-2015-00007
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    April 2, 2014
    Report Date
    August 13, 2015
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    JWH
    PMA / PMN Number
    K113829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION SHOWED AN ANOMALY IN PLACEMENT OF A LANDMARK. THIS LANDMARK HAS A DIRECT IMPACT ON THE POSITION OF THE HOOKING FEATURE OF THE PATIENT SPECIFIC GUIDE. DUE TO THE DEVIATING PLACEMENT OF THIS LANDMARK THE FEATURE WAS POSITIONED TOO POSTERIOR ON THE TIBIA. THIS CAUSED THAT THE CONTACT SURFACE OF THE GUIDE AROUND THIS FEATURE WAS NOTICEABLY REDUCED AFTER UNDERCUTS WERE REMOVED. THIS POTENTIALLY MADE IT POSSIBLE FOR THE GUIDE TO SHIFT MORE POSTERIOR/DISTAL AND THEREFORE POSSIBLY COULD HAVE CONTRIBUTED TO THE ERROR STATED BY THE SURGEON, NAMELY THAT THERE WAS EXCESSIVE SLOPE IN : NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENTS GUIDES. IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED. TIBIA COMPONENT WAS REMOVED BECAUSE OF INSTABILITY AND PAIN. IT WAS ALSO DETERMINED THAT THERE WAS EXCESSIVE SLOPE IN THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601788 ZIMMER® PATIENT SPECIFIC INSTRUMENT KNEE PROSTHESIS JWH MATERIALISE USA, LLC 00-5970-000-18 56589157

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention