BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 2212168 · Received July 8, 2011

    Report

    Report Number
    9616680-2011-00462
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    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 SALES REP REPORTED ON BEHALF OF THE CUSTOMER THAT THE LABELLING WAS CORRECT, BUT THE SURGEON THINKS IT MIGHT BE THE WRONG SIZE. IT WAS FURTHER REPORTED THAT THIS WAS NOTICED DURING PREPARATION FOR SURGERY AND THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 36042802

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other