BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 3397323 · Received October 9, 2013

    Report

    Report Number
    0002249697-2013-03274
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    September 24, 2012
    Report Date
    May 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LACK OF MOBILITY AND PAIN INVOLVING A SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON WITH NO REPORTED DISCREPANCIES. A SEARCH OF THE COMPLAINT DATABASES INDICATED THAT S EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. VOLUNTARY RECALL RA 2012-171 WERE INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED LACK OF MOBILITY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; PATIENT IS EXPERIENCING PAIN, LACK OF MOBILITY AFTER SURGERY USING SHAPEMATCH CUTTING GUIDE INVOLVING RIGHT KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; PATIENT IS EXPERIENCING PAIN, LACK OF MOBILITY AFTER SURGERY USING SHAPEMATCH CUTTING GUIDE INVOLVING RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513363 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12264013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other