BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA SOLID BACK 62MM

    MDR report key: 1080425 · Received July 21, 2008

    Report

    Report Number
    9616680-2008-00214
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 4, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA SOLID BACK 62MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 10184961CL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other