BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG X3 INSERT 32MM HEAD

    MDR report key: 4102968 · Received September 19, 2014

    Report

    Report Number
    0002249697-2014-03573
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. INSUFFICIENT INFORMATION WAS RECEIVED FOR MEDICAL EVALUATION. DEVICE HISTORY REVIEW. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT AND STERILE LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER AND LOT CODE OF OTHER DEVICE LISTED IN THIS REPORT: CAT # 18-32-3, LOT # 122318, DESCRIPTION: DELTA C-TAPER HEAD 32MM -2.5. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. KEPT BY PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO PAIN AND INFECTION. THIS WAS A POLY / HEAD EXCHANGE DUE TO PAIN AND POSSIBLE INFECTION - A WASH OUT WAS DONE AND A NEW LINER AND HEAD WERE PUT IN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO PAIN AND INFECTION. THIS WAS A POLY / HEAD EXCHANGE DUE TO PAIN AND POSSIBLE INFECTION - A WASH OUT WAS DONE AND A NEW LINER AND HEAD WERE PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584980 TRIDENT 0 DEG X3 INSERT 32MM HEAD IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMNP2R

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention