BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 3226409 · Received July 15, 2013

    Report

    Report Number
    0002249697-2013-02290
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 DUE TO HOSPITAL POLICY. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT AND STERILE LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED. 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

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 18-3675, LOT 19252103, DESCRIPTION: DELTA C-TAPER HEAD 36MM +7.5; CAT 542-11-54F, LOT 23602001, DESCRIPTION: TRIDENT PSL HA CLUSTER 54MM; CAT 6054-1115S, LOT 3R1MTA, DESCRIPTION: PRIMARY SECUR-FIT PLUS MAX #11/15. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    INFECTION.

    Description of Event or Problem · 1

    INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325332 TRIDENT 10° X3 INSERT 36MM ID IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 2NRMRA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention