BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10 X3 INSERT 32MM ID

    MDR report key: 1915391 · Received November 17, 2010

    Report

    Report Number
    9616680-2010-00740
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    I WAS REPORTED THAT DURING SURGERY, THE SURGEON TRIED TO IMPACT THE LINER INTO THE SHELL AND THE LINER DID NOT LOCK INTO PLACE. IT IS FURTHER REPORTED THAT ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE SURGERY WITH ONLY 5 MINUTES ADDED SURGERY TIME. IT IS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 X3 INSERT 32MM ID IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 33300701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other