BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR SHORT NECK

    MDR report key: 3131404 · Received May 13, 2013

    Report

    Report Number
    9616680-2013-90158
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    January 1, 2012
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BEEN EXPERIENCING SEVERE PAIN SINCE THE TIME OF THE IMPLANT. THE PT HAD THE STANDARD PHYSICAL THERAPY BUT THE PAIN HAS NOT ABATED. THE PAIN IS EXCRUCIATING. SHE IS CURRENTLY TAKING PAIN MEDICATION. THE PT SCHEDULED AN APPOINTMENT WITH HER SURGEON BECAUSE OF THE CONTINUING PAIN; IT WAS AT THAT TIME SHE WAS INFORMED OF THE RECALL. IT IS REPORTED THAT THE PT'S BLOOD TEST SHOWED HIGHLY ELEVATED CHROMIUM AND COBALT LEVELS. THE PT IS BEING SCHEDULED FOR AN MRI. ADDITIONAL EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION. PT....

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211666 ABGII MODULAR SHORT NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G3029547

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention