BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM 0MM V40 ALUMINA HEAD

    MDR report key: 2090154 · Received May 6, 2011

    Report

    Report Number
    9616680-2011-00285
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    IT WAS REPORTED THAT, "ACCORDING TO THE SURGEON THE PT CLAIMED TO HAVE HIP PAIN. THE X-RAYS SHOWED THAT THE IMPLANTS WERE IN GOOD POSITION. PT WAS REVISED FOR HIP PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 28MM 0MM V40 ALUMINA HEAD IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 6895501

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention