BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 58MM

    MDR report key: 2020660 · Received March 7, 2011

    Report

    Report Number
    2249697-2011-00266
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 MFR. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PRE-OP: DISLOCATION, CUP IN NEUTRAL POSITION, NOT ENOUGH ANTEVERSION - PLANS REVISED CUP. OUTCOME: 60MM TRITANIUM CLUSTER SHELL, 40MM X 3, SZ F, LINER, 40MM +0 HEAD, C-TAPER, STABLE HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 58MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 22861502

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R