BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 3243795 · Received July 23, 2013

    Report

    Report Number
    0002249697-2013-02411
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    November 18, 2011
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND INSTABILITY INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE REPORTED INSTABILITY COULD NOT BE CONFIRMED, HOWEVER, THE PAIN WAS CONFIRMED. THE DEVICES REMAIN IMPLANTED AND WERE, THEREFORE, NOT RETURNED FOR ANALYSIS. REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THE REPORTED PAIN IS CAUSED BY PERIPHERAL NEUROPATHY. THE DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED PAIN IS CAUSED BY PERIPHERAL NEUROPATHY, OR PAIN DUE TO NERVE DAMAGE. HOWEVER, THE REPORTED INSTABILITY COULD NOT BE CONFIRMED. THERE IS NO INDICATION IN THE PROVIDED INFORMATION OR MEDICAL RECORDS THAT THIS EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT STATES PAIN. KNEE BENDS BACKWARDS TO FAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT STATES PAIN. KNEE BENDS BACKWARDS TO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342926 TRIATHLON PS FEM COMPONENT, CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EBSP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention