BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 3563133 · Received January 8, 2014

    Report

    Report Number
    0002249697-2014-00113
    Event Type
    Injury
    Date Received
    January 8, 2014
    Date of Event
    March 28, 2012
    Report Date
    August 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A SEARCH OF THE COMPLAINT DATABASES INDICATES SIMILAR EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. VOLUNTARY RECALL RA 2012-171 WAS INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. AS A RESULT OF AN INTERNAL NONCONFORMANCE THE FOLLOWING ROOT CAUSES WERE IDENTIFIED: INADEQUATE DESIGN CONTROLS ; INADEQUATE USER TRAINING ; INSUFFICIENT QUALITY CONTROL MEASURES. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS A RIGHT KNEE. PATIENT COMPLAINS OF EXTREME PAIN AND INABILITY TO WALK ANY TYPE OF DISTANCE. PATIENT IS ALSO COMPLAINING OF A METAL TASTE IN HER MOUTH AND PAIN SHOOTING UP THROUGH HER THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12317 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12059010

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention