BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 2150528 · Received June 23, 2011

    Report

    Report Number
    9616680-2011-00417
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISION HIP BECAUSE OF PATIENT COMPLAINING OF RIGHT HIP PAIN. IMPLANTED IN 2010. REVISED EXISTING TRIDENT PSL SHELL BECAUSE NO ONGROWTH PUT IN 54MM TRITANIUM SHELL AND REPLACED HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 33264901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention