BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 38MM

    MDR report key: 2872153 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01323
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    January 17, 2010
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT COMPLAINS OF PAIN THAT STARTED IN THE PAST OF COUPLE OF WEEKS. PT HAS SWELLING SINCE LAST MONTH AND REPORTS THAT WHEN LAYING DOWN HE CAN FEEL THE SWELLING. MRI SHOWS FLUID BUILD UP. DOCTOR ASPIRATED ON (B)(6) 2012. X-RAY SHOWED BONE DETERIORATION. REVISION SURGERY IS SCHEDULED FOR NOVEMBER 2012. ADDITIONAL INFORMATION REPORTED VIA SALES REP (B)(6) 2012: IT WAS REPORTED THAT THE COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 38MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 24945402

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention