BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 8DEG 30MM

    MDR report key: 2893475 · Received December 21, 2012

    Report

    Report Number
    9616680-2012-01478
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR (B)(6) STATES THE PT PRESENTED INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 8DEG 30MM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 31893901

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R