BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3214072 · Received July 9, 2013

    Report

    Report Number
    0002249697-2013-02240
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    January 1, 2011
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN RIGHT TRIDENT HIP IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CLICKING NOISE IN A TRIDENT CERAMIC BEARING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. THE COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. A REVIEW OF THE PROVIDED RECORDS BY A CLINICAL CONSULTANT CONCLUDED: "BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO CONFIRM THE ACCURACY OR DETERMINE THE CAUSE OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION." CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED CLICKING NOISE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. 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, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HEARING A LOUD CLICKING NOISE IN HIS HIP. PATIENT STATES THAT THE NOISE HAS INCREASED WITHIN THE LAST SIX MONTHS. PATIENT REPORTS THAT THE NOISE FIRST STARTED TWO YEARS AGO AND HAS PROGRESSIVELY GOTTEN WORSE. PATIENT IS UPSET AND EMBARRASSED AND FEELS THAT IF HE HAS TO HAVE REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HEARING A LOUD CLICKING NOISE IN HIS HIP. PATIENT STATES THAT THE NOISE HAS INCREASED WITHIN THE LAST SIX MONTHS. PATIENT REPORTS THAT THE NOISE FIRST STARTED TWO YEARS AGO AND HAS PROGRESSIVELY GOTTEN WORSE. PATIENT IS UPSET AND EMBARRASSED AND FEELS THAT IF HE HAS TO HAVE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314155 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH 19213703

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other