BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #3 R-CEM

    MDR report key: 3870323 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02210
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING INSTABILITY AND ARTHROFIBROSIS INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT OF ARTHROFIBROSIS WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: A PHOTO WAS PROVIDED, BUT IT IS OF POOR QUALITY. THERE APPEARS TO BE BONE ONGROWTH. NOTHING FURTHER CAN BE LEARNED FROM THE PHOTO. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: NO PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY OPERATIVE REPORT OR DATES OF SURGERY ARE AVAILABLE. THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS AND NO X-RAYS AVAILABLE FOR REVIEW. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CASE OF LIKELY POST-TKA ARTHROFIBROSIS. 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 EXACT CAUSE OF THE ARTHROFIBROSIS COULD NOT BE DETERMINED BECAUSE. ADDITIONAL INFORMATION, SUCH AS THE EXPLANTED COMPONENTS, AND X-RAYS ARE NEEDED FOR DETERMINING THE ROOT CAUSE; HOWEVER, THE CONSULTANT INDICATED THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CASE OF LIKELY POST-TKA ARTHROFIBROSIS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICES WERE RETAINED AT DREXEL IMPLANT RESEARCH CENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND ANKYLOSIS. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROXIMATELY 6.51 Y. THE TIBIAL INSERT AND FEMORAL COMPONENT WAS REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 5.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND ANKYLOSIS. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 6.51 Y. THE TIBIAL INSERT AND FEMORAL COMPONENT WAS REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347437 TRIATHLON CR FEM COMP #3 R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SB9RR

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention