BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL MULTI

    MDR report key: 2850827 · Received November 21, 2012

    Report

    Report Number
    9616680-2012-01159
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION, NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LETTER RECEIVED FROM PT'S LAWYER OUTLINING THE PT WAS REVISED, AS SHE HAS SUFFERED PAIN AND RESTRICTION OF MOBILITY. HER SURGEON HAS INFORMED HER THAT THE BONE HAS NOT AFFIXED TO THE IMPLANT. SURGEON FURTHER ADVISED HER THAT REVISION OF SURGERY WILL BE DIFFICULT AND MAY RESULT IN BEING WHEELCHAIR BOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL MULTI IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other