BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY

    MDR report key: 3501579 · Received December 5, 2013

    Report

    Report Number
    0002249697-2013-03895
    Event Type
    Injury
    Date Received
    December 5, 2013
    Date of Event
    August 24, 2012
    Report Date
    September 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION 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 WITH NO REPORTED DISCREPANCIES. A SEARCH OF THE COMPLAINT DATABASES INDICATES THAT SIMILAR EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. CONCLUSIONS: A MEDICAL CONSULTANT HAS INDICATED THAT "NO PREOPERATIVE OR POSTOPERATIVE RADIOGRAPHS ARE AVAILABLE FOR REVIEW. THE SHAPEMATCH BLOCKS WERE NOT AVAILABLE TO REVIEW FOR MANUFACTURING SPECIFICATIONS." VOLUNTARY RECALL RA 2012-171 WAS INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED REVISION 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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS KNEE LOCKED UP AND SWELLED. PATIENT WAS IN PAIN AND HER KNEE PROGRESSIVELY GOT WORSE. SURGEON DECIDED TO REVISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS KNEE LOCKED UP AND SWELLED. PATIENT WAS IN PAIN AND HER KNEE PROGRESSIVELY GOT WORSE. SURGEON DECIDED TO REVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631093 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12215048

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention