BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 3852198 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02140
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    November 15, 2011
    Report Date
    May 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER TRIATHLON KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING ARTHROFIBROSIS INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, ¿X-RAY COPIES AVAILABLE FOR REVIEW INCLUDE A SERIES DATED (B)(6) 2011, WHICH IS AN AP AND LATERAL OF THE RIGHT KNEE, DEMONSTRATING A CEMENTED RIGHT TOTAL KNEE ARTHROPLASTY WITH ALL COMPONENTS IN NOMINAL POSITION. [¿] A (B)(6) 2012 AP AND LATERAL OF THE RIGHT KNEE AND PATELLAR VIEW OF BOTH KNEES ARE OF POOR QUALITY, BUT DEMONSTRATE NO GROSS CHANGES IN THE APPEARANCE OF THE RIGHT TOTAL KNEE. THERE IS NO EVIDENCE THAT THE POST-OPERATIVE ARTHROFIBROSIS IN THE RIGHT TOTAL KNEE ARTHROPLASTY WAS RELATED TO FACTORS OF COMPONENT DESIGN, MANUFACTURING, OR MATERIALS.¿ 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: A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED ARTHROFIBROSIS MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. THE CLINICAL CONSULTANT NOTED THE COMPONENTS WERE IN NOMINAL POSITION AND CONCLUDED THAT THERE IS NO EVIDENCE THAT THE POST-OPERATIVE ARTHROFIBROSIS IN THE RIGHT TOTAL KNEE ARTHROPLASTY WAS RELATED TO FACTORS OF COMPONENT DESIGN, MANUFACTURING, OR MATERIALS. THE FOLLOWING ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 5520-B-300, TRIATHLON PRIM TIB BASEPLATE - CEMENTED, LOT CODE: FPZP; CAT. NO.: 5510-F-402, TRIATHLON CR FEM COMP #4 R-CEM, LOT CODE: S343L; CAT. NO.: 5551-G-299, TRIATHLON ASYMMETRIC X3 PATELLA, LOT CODE: TW9R.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRIMARY SURGERY ON (B)(6) 2011 WITH A STRYKER RIGHT TRIATHLON KNEE. PATIENT HAD PAIN, LIMITED RANGE OF MOTION AND SWELLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRIMARY SURGERY ON (B)(6) 2011 WITH A STRYKER RIGHT TRIATHLON KNEE. PATIENT HAD PAIN, LIMITED RANGE OF MOTION AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329009 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MHR5PW

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other