BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON #4 PS INSERT 11MM

    MDR report key: 3305073 · Received August 23, 2013

    Report

    Report Number
    0002249697-2013-02835
    Event Type
    Injury
    Date Received
    August 23, 2013
    Date of Event
    November 11, 2011
    Report Date
    August 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT STRYKER KNEE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN, INSTABILITY, AND A CLICKING NOISE INVOLVING AN UNKNOWN LEFT STRYKER KNEE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    BRAND NAME: TRIATHLON #4 PS INSERT 11MM. PRODUCT CODE: JWH. CATALOG #: 5532-P-411. LOT #: LCO633. EXPIRATION DATE: 09/30/2016. OTHER # (STERILE LOT #): M9156. MANUFACTURING SITE FOR DEVICES: (B)(4). PMA/510(K) #: K031729. DEVICE MANUFACTURE DATE: 09/08/2011. AN EVENT REGARDING ALLEGED PAIN AND SWELLING ASSOCIATED WITH ARTHROFIBROSIS INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. X-RAY PRINTOUTS, ALL UNDATED, INCLUDE TWO AP¿S AND THREE LATERALS OF THE RIGHT KNEE DEMONSTRATING OSTEOARTHRITIS, AND SEVEN AP¿S OF THE LEFT, ONE AP OF BOTH KNEES AND EIGHT LATERALS OF THE LEFT ALL DEMONSTRATING A CEMENTED PS TOTAL KNEE ARTHROPLASTY IN NOMINAL POSITION WITH NO PATHOLOGY. THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENT AND NO PATELLAR X-RAYS CONFIRMING THE ¿TILTING OF KNEECAP¿ NOTED ON OCTOBER 9, 2014. THERE HAVE BEEN NO RELEVANT REPORTED DISCREPANCIES FOR THE REFERENCED LOT. THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: THIS CLINICAL PICTURE COULD BE THE RESULT OF ARTHROFIBROSIS AND/OR PATELLA MALTRACKING. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS ARE RESPONSIBLE FOR THIS CLINICAL SITUATION. 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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS KNEE GETS VERY SWOLLEN AND HAS PAIN. PATIENT ALSO STATES THAT WALKING IS UNSTABLE AND MAKES A CLICKING NOISE.

    Description of Event or Problem · 1

    UPDATE PER PATIENT: PATIENT HAD A REVISION SURGERY ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS KNEE GETS VERY SWOLLEN AND HAS PAIN. PATIENT ALSO STATES THAT WALKING IS UNSTABLE AND MAKES A CLICKING NOISE UPDATE PER PATIENT: PATIENT HAD A REVISION SURGERY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409822 TRIATHLON #4 PS INSERT 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCO633

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other