BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 50MM

    MDR report key: 2000393 · Received February 9, 2011

    Report

    Report Number
    9616680-2011-00056
    Event Type
    Other
    Date Received
    February 9, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    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. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT REPORTED GROIN PAIN TO SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 20350501

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other