BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10 X3 INSERT 32MM ID

    MDR report key: 1193507 · Received October 8, 2008

    Report

    Report Number
    2249697-2008-00300
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON IMPACTED INSERT INTO SHELL. HE THEN IMPLANTED STEM, PLACED TRIAL HEAD AND PERFORMED FINAL TRIAL. UPON DISLOCATION, THE AFFECTED INSERT BECAME DISASSOCIATED WITH PSL SHELL. SURGEON STATED THAT HE "LOST CONFIDENCE" IN SAID INSERT AND ASKED FOR NEW WHICH WAS PLACED INTO AND SECURED INTO SHELL. FINAL HEAD IMPLANT WAS PLACED AND SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 X3 INSERT 32MM ID IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA HWYMTD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other