BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 1881167 · Received October 20, 2010

    Report

    Report Number
    9616680-2010-00660
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    July 24, 2009
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CLINICAL DEPARTMENT RECEIVED DELIVERABLE WHICH WAS INDICATED AS A CONTACT MILESTONE FROM THE SITE WITH INFORMATION ON F/U APPOINTMENTS. THE SPREAD SHEET IDENTIFIED SUBJECTS WHO REQUIRED REVISIONS FOLLOWING THA. RIGHT LOOSE ACETABULAR CUP. SURGERY DATE (B)(6)2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 23687601

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention