BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY

    MDR report key: 3397369 · Received October 9, 2013

    Report

    Report Number
    0002249697-2013-03279
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REDUCED RANGE OF MOTION INVOLVING A SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. ADDITIONALLY, PATIENT MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE ACCEPTED AND MANUFACTURED WITH NO REPORTED DISCREPANCIES. A SEARCH OF THE COMPLAINT DATABASES INDICATED SIMILAR EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. CONCLUSIONS: VOLUNTARY RECALL RA 2012-171 WERE INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED REDUCED RANGE OF MOTION 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 AND INSUFFICIENT QUALITY CONTROL MEASURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR ATTEMPTED MANIPULATION. PATIENT WAS TIGHT IN FLEXION. CHOSE TO OPERATIVELY LOOSEN TENDONS. REMOVED LINER AND REPLACED WITH ANOTHER LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR ATTEMPTED MANIPULATION. PATIENT WAS TIGHT IN FLEXION. CHOSE TO OPERATIVELY LOOSEN TENDONS. REMOVED LINER AND REPLACED WITH ANOTHER LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511745 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12236016

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention