BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 4119245 · Received September 25, 2014

    Report

    Report Number
    0002249697-2014-03605
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN IN THE RIGHT KNEE INVOLVING A US SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS REVIEWED BY A CONSULTING CLINICIAN WHO CONCLUDED: ¿OTHER THAN A MILD RIGHT INFRAPATELLAR TENDONITIS, THE CLINICAL AND RADIOGRAPHIC PROGRESS OF HIS TOTAL KNEE ARTHROPLASTIES WAS SATISFACTORY. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING, OR MATERIALS ARE RESPONSIBLE FOR THIS CLINICAL SITUATION.¿ DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: PAIN CAN OCCUR POST-OPERATIVELY FOR A NUMBER OF REASONS AND IS A SYMPTOM RATHER THAN THE CAUSE OF THE ISSUE THE PATIENT IS EXPERIENCING. NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. A SEARCH OF THE SUPER AND CHS COMPLAINT DATABASES INDICATED OTHER EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH A VOLUNTARY HOLD AND VOLUNTARY RECALL RA 2012-171. CONCLUSIONS: THE PROVIDED MEDICAL INFORMATION WAS EVALUATED BY A CONSULTING CLINICIAN WHO CONCLUDED: ¿OTHER THAN A MILD RIGHT INFRAPATELLAR TENDONITIS, THE CLINICAL AND RADIOGRAPHIC PROGRESS OF HIS TOTAL KNEE ARTHROPLASTIES WAS SATISFACTORY.¿

    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 IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN AND NEEDS A REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN AND NEEDS A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597498 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12163016

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention