BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT CR#2 11MM

    MDR report key: 3781205 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01661
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    November 4, 2011
    Report Date
    October 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MANIPULATION UNDER ANESTHETIC INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: WHILE THIS CASE WAS WITHIN THE SCOPE OF PRODUCT RECALL REGULATORY ACTION 2013-060, THIS PI WAS NOT FELT TO BE RELATED TO THE SHAPEMATCH CUTTING JIGS. THE FAILURE TO REGAIN MOTION POSTOPERATIVELY IS NOT FELT RELATED TO THE DEVICE. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT FAILURE TO REGAIN MOTION AFTER KNEE REPLACEMENT IS MULTIFACTORIAL. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: THE PI AS SUBMITTED 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 2013-060, THIS PI WAS NOT FELT TO BE RELATED TO THE SHAPEMATCH CUTTING JIGS. THE FAILURE TO REGAIN MOTION POSTOPERATIVELY IS NOT FELT RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE OF THE SHAPEMATCH CLINICAL TRIAL DATA IT WAS DISCOVERED THE PATIENT HAD REQUIRED MANIPULATION UNDER ANAESTHETIC.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE SHAPEMATCH CLINICAL TRIAL DATA IT WAS DISCOVERED THE PATIENT HAD REQUIRED MANIPULATION UNDER ANAESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260300 X3 TRIATHLON INSERT CR#2 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCH696

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention