BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #5 R-CEM

    MDR report key: 3925580 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02603
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    December 4, 2013
    Report Date
    May 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND A POSSIBLE ALLERGIC REACTION INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICE WAS RETURNED FOR REVIEW. THE PATIENT HAS A DOCUMENTED ALLERGY TO NICKEL AND IS TO UNDERGO FURTHER TESTING TO ESTABLISH IF SHE HAS AN ALLERGY TO OTHER METALS. CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED INDICATED THAT THERE IS NO EVIDENCE THAT THE SYMPTOMS DESCRIBED IN THIS OBESE PATIENT WITH MULTIPLE SYSTEMIC DISORDERS ARE RELATED TO FACTORS OF FAULTY DESIGN, MANUFACTURING, OR MATERIALS OF THE COMPONENTS OR AN ALLERGIC REACTION TO THEM. DEVICE HISTORY REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO PREVIOUS REPORTED EVENTS FOR THIS LOT ID. THE REPORTED EVENT RELATING TO THE PATIENTS SUSPECTED ALLERGY CANNOT BE CONFIRMED. FURTHER TESTS ARE REQUIRED TO ESTABLISH IF THE PATIENT HAS AN ALLERGY TO THE IMPLANT MATERIALS. THE MATERIAL COMPOSITION OF THE IMPLANTS IS REFERRED TO IN THE PRODUCT IFU FOR THE TREATING SURGEON TO REFER TO. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT REPORTED PAIN SINCE RIGHT KNEE SURGERY. PATIENT HAS BEEN DOING PHYSICAL THERAPY SINCE SURGERY AND SAYS SHE HAS NO RELIEF. PATIENT SAYS HER LEFT KNEE IS 5 INCHES IN DIAMETER AND RIGHT KNEE IS 9 INCHES IN DIAMETER AND THERE IS NO FLUID TO DRAIN OFF. SHE IS ALLERGIC TO NICKEL AND IN A FEW WEEKS SHE WILL BE TESTED FOR ALLERGIES TO OTHER METALS. PATIENT WANTS TO KNOW WHAT DEVICE IS MADE OF.

    Description of Event or Problem · 1

    PATIENT REPORTED PAIN SINCE RIGHT KNEE SURGERY. PATIENT HAS BEEN DOING PHYSICAL THERAPY SINCE SURGERY AND SAYS SHE HAS NO RELIEF. PATIENT SAYS HER LEFT KNEE IS 5 INCHES IN DIAMETER AND RIGHT KNEE IS 9 INCHES IN DIAMETER AND THERE IS NO FLUID TO DRAIN OFF. SHE IS ALLERGIC TO NICKEL AND IN A FEW WEEKS SHE WILL BE TESTED FOR ALLERGIES TO OTHER METALS. PATIENT WANTS TO KNOW WHAT DEVICE IS MADE OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404626 TRIATHLON CR FEM COMP #5 R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH S8MDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other