BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA CLUSTER 54MM

    MDR report key: 1113313 · Received August 12, 2008

    Report

    Report Number
    9616680-2008-00244
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FLAKE OF METAL ON THE RING WHERE THE IMPACTOR THREADS INTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25755501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other