BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY

    MDR report key: 3512022 · Received December 10, 2013

    Report

    Report Number
    0002249697-2013-03971
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A POSTERIORLY SLOPED TIBIAL TRAY INVOLVING A SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS CONFIRMED. 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 POSTERIORLY SLOPED TIBIAL TRAY IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. AS A RESULT OF AN INTERNAL NONCONFORMANCE THE FOLLOWING ROOT CAUSES WERE IDENTIFIED: 1. INADEQUATE DESIGN CONTROLS , 2. INADEQUATE USER TRAINING, 3. INSUFFICIENT QUALITY CONTROL MEASURES.

    Description of Event or Problem · 1

    LEFT KNEE REVISION OF TRIATHLON CR, THAT WAS A SHAPEMATCH KNEE. PATIENT COMPLAINED OF LEFT KNEE PAIN AND UPON REVIEW OF X-RAY, THE TIBIAL TRAY WAS SLOPED POSTERIORLY. TRIATHLON TS WAS USED AS REVISION REPLACEMENT SYSTEM.

    Description of Event or Problem · 1

    LEFT KNEE REVISION OF TRIATHLON CR, THAT WAS A SHAPEMATCH KNEE. PATIENT COMPLAINED OF LEFT KNEE PAIN AND UPON REVIEW OF X-RAY, THE TIBIAL TRAY WAS SLOPED POSTERIORLY. TRIATHLON TS WAS USED AS REVISION REPLACEMENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642933 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 11350017

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention