BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 1884541 · Received October 21, 2010

    Report

    Report Number
    2249697-2010-01391
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    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 WAS NOT RETURNED TO THE MANUFACTURER AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING TOTAL HIP ARTHROPLASTY, THE TRIDENT X-3 36M D LINER WAS INSERTED INTO A SUMM TRITANIUM SOLID BACK SHELL. THE LINER WAS IMPACTED AND SEATED AND A TRIAL REDUCTION WAS DONE. AFTER DISLOCATION, DR. OBSERVED SEVERAL DEEP SCRATCHES ON THE INSIDE OF THE LINER OF UNKNOWN ORIGIN. DR WAS CONCERNED AND DECIDED TO REMOVE THE LINER AND REPLACE IT WITH A NEW ONE. DR STATES THAT CARE WAS TAKEN WITH THE PLACEMENT OF HIS RETRACTORS AND THAT WAS NOT THE CAUSE. WE THEN TURNED OUR ATTENTION TO THE LINER IMPACTOR AND TRIAL HEADS TO CHECK FOR ROUGH SPOTS OR DIVOTS IN THE PLASTIC NONE WERE OBSERVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 36MM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MJNPNL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention