BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY

    MDR report key: 3691060 · Received March 20, 2014

    Report

    Report Number
    0002249697-2014-00832
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 24, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

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

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING PAIN INVOLVING A US SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & 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: ¿THE PI AS SUBMITTED ALTHOUGH WITH LIMITED DATA DOES NOT APPEAR TO BE RELATED TO THE USE OF SHAPE MATCH CUTTING GUIDES OR THE TRIATHLON IMPLANT. WHILE THIS CASE WAS WITHIN THE SCOPE OF PRODUCT RECALL REGULATORY ACTION 2012-171, THIS PI WAS NOT FELT TO BE RELATED TO THE SHAPEMATCH CUTTING JIGS.¿ -DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATES THAT THIS DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: 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 RECALL RA 2012-171. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    MAUDE REPORT, MW5033716, REPORTED: "VOLUN 08-JAN-2014: HAD MY KNEES REPLACED (RIGHT ONE ON (B)(6) 2011 AND SECOND ONE, ON (B)(6) 2011) USING STRYKER SHAPE MATCH CUTTING GUIDE. NOW, ALMOST 2 YEARS LATER, HAVING SEVERE PAIN IN MY LEFT KNEE. SEEING MY SURGEON'S ASSISTANT TOMORROW TO SEE WHAT IS GOING ON (B)(6) 2014). I CANNOT WALK, BEND MY KNEE WITHOUT PAIN. WENT THROUGH ALL OF THIS TWICE ALREADY, FIRST TIME THE RIGHT, WITH SURGERY, RECOVERY AND THERAPY AND THEN THE LEFT. I AM TIRED OF PAIN."

    Description of Event or Problem · 1

    (B)(4), REPORTED: "VOLUN (B)(6) 2014: HAD MY KNEES REPLACED (RIGHT ONE ON (B)(6) 2011 AND SECOND ONE, ON (B)(6) 2011) USING STRYKER SHAPE MATCH CUTTING GUIDE. NOW, ALMOST 2 YEARS LATER, HAVING SEVERE PAIN IN MY LEFT KNEE. SEEING MY SURGEON'S ASSISTANT TOMORROW TO SEE WHAT IS GOING ON (B)(6) 2014). I CANNOT WALK, BEND MY KNEE WITHOUT PAIN. WENT THROUGH ALL OF THIS TWICE ALREADY, FIRST TIME THE RIGHT, WITH SURGERY, RECOVERY AND THERAPY AND THEN THE LEFT. I AM TIRED OF PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165955 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 11334012

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other