BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 3140938 · Received June 3, 2013

    Report

    Report Number
    0002249697-2013-01843
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    November 5, 2012
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY OF THE KNEE INVOLVING A TRIATHLON TIBIAL INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. CONCLUSIONS: THE REPORTED EVENT DESCRIPTION INDICATED THAT ¿THE OPINION OF THE SURGEON IS THAT THE EVENT IS RELATED TO THE SPECIFIC STUDY DEVICE AND SURGERY PROCEDURE.¿ BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    (B)(6) PRINCIPAL INVESTIGATOR OF (B)(6) REPORTED THROUGH ADVERSE EVENT REPORT FORM AN EVENT OF FAILURE OF THE IMPLANTED DEVICE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE OF TKR ON (B)(6) 2012. DURING POST OPERATIVE EXAMINATION IT WAS NOTED KNEE INSTABILITY. THE OPINION OF THE SURGEON IS THAT THE EVENT IS RELATED TO THE SPECIFIC STUDY DEVICE AND SURGERY PROCEDURE. ON (B)(6) 2013 THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE INSERT WAS EXPLANTED . THE PATIENT IS STILL IN THE HOSPITAL, COMPLETING THE PHYSIOTHERAPEUTIC TREATMENT. ADDITIONAL INFORMATION, FROM THE PATIENT'S MEDICAL RECORDS, RECEIVED ON (B)(6) 2013 INDICATES "PREVIOUS MEDIAL PARAPATELLAR SURGICAL ACCESS WAS USED. IT WAS OBSERVED PERIPROSTHETIC LATERAL CONDYLAR AND PERI PATELLAR FIBROSIS, IT WAS REMOVED. AFTER THAT IT WAS REMOVED THE POLYETHYLENE INSERT AND AN TRIAL INSERT HAS BEEN INSERTED (13MM). STABILITY TESTS SHOWED GOOD JOINTS STABILITY. IT WAS PLACED THE DEFINITIVE INSERT TRIATHLON CS 13MM SIZE 5."

    Description of Event or Problem · 1

    (B)(6) OF CLINICAL STUDY "(B)(6)" REPORTED THROUGH ADVERSE EVENT REPORT FORM AN EVENT OF FAILURE OF THE IMPLANTED DEVICE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE OF TKR ON (B)(6) 2012. DURING POST OPERATIVE EXAMINATION IT WAS NOTED KNEE INSTABILITY. THE OPINION OF THE SURGEON IS THAT THE EVENT IS RELATED TO THE SPECIFIC STUDY DEVICE AND SURGERY PROCEDURE. ON (B)(6) 2013 THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE INSERT WAS EXPLANTED . THE PATIENT IS STILL IN THE HOSPITAL, COMPLETING THE PHYSIOTHERAPEUTIC TREATMENT. ADDITIONAL INFORMATION, FROM THE PATIENT'S MEDICAL RECORDS, RECEIVED ON (B)(6) 2013 INDICATES "PREVIOUS MEDIAL PARAPATELLAR SURGICAL ACCESS WAS USED. IT WAS OBSERVED PERIPROSTHETIC LATERAL CONDYLAR AND PERI PATELLAR FIBROSIS, IT WAS REMOVED. AFTER THAT IT WAS REMOVED THE POLYETHYLENE INSERT AND AN TRIAL INSERT HAS BEEN INSERTED (13MM). STABILITY TESTS SHOWED GOOD JOINTS STABILITY. IT WAS PLACED THE DEFINITIVE INSERT TRIATHLON CS 13MM SIZE 5."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244371 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MJRVTA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention