BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 3140754 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01838
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 1, 2012
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE BASED ON ADDITIONAL INFORMATION. THE PATIENT IS (B)(6) IN HEIGHT. THIS EVENT IS RELATED TO VOLUNTARY RECALL RA 2012-067. THIS RECALL WAS INITIATED DUE TO THE POTENTIAL RISKS ASSOCIATED WITH MODULAR NECK STEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING HEADACHES, TIREDNESS, NAUSEA AND PAIN. ADDITIONAL INFORMATION: IT WAS REPORTED THAT DR. (B)(6) STATES PATIENT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN. DR (B)(6) DECIDED TO EXCHANGE LINER BECAUSE OF COLOR/WEAR CHANGES TO LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING HEADACHES, TIREDNESS, NAUSEA AND PAIN. ADDITIONAL INFORMATION: IT WAS REPORTED THAT DR. (B)(6) STATES PATIENT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN. DR. (B)(6) DECIDED TO EXCHANGE LINER BECAUSE OF COLOR/WEAR CHANGES TO LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241634 TRIDENT 10° X3 INSERT 36MM ID IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MKDRH0

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention