BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 1812881 · Received August 12, 2010

    Report

    Report Number
    9616680-2010-00513
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    P000013
    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

    THE CUSTOMER REPORTED VIA THE SALES REP THAT DURING SURGERY THE SURGEON COULD NOT GET THE CERAMIC LINER SEATED IN THE TRIDENT SHELL. THE SALES REP FURTHER REPORTED THAT THE UNIT WOULD NOT LOCK INTO PLACE AND WAS VERY LOOSE. THE SALES REP FURTHER STATED THAT THE SURGERY WAS COMPLETED USING ANOTHER UNIT. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALUMINA INSERT IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 33861003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other