BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 3163098 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01882
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 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
    OTHER

    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. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT DESCRIPTION CONSISTENT WITH THE HARMS ASSOCIATED WITH (B)(4) WAS REPORTED. THE EVENT NOTED THAT THE LINER WAS REVISED DUE TO "DISCOLORATION." THE EVENT DID NOT ALLEGE ANY FUNCTIONAL DEFICIENCY OR FAILURE OF THE SUBJECT ACETABULAR LINER AT THE TIME OF REVISION. DISCOLORATION IS A KNOWN EFFECT OF USE ATTRIBUTED TO IN-VIVO ABSORPTION OF SYNOVIAL FLUID AND DOES NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. BASED ON THIS INFORMATION, IT IS BELIEVED THE LINER WAS REPLACED AS A PRECAUTIONARY MEASURE WHILE IT WAS EASILY ACCESSIBLE.

    Description of Event or Problem · 1

    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 EXHANGE LINER BECAUSE OF DISCOLORATION OF LINER.

    Description of Event or Problem · 1

    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 DISCOLORATION OF LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263661 TRIDENT 10° X3 INSERT 36MM ID IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MJD14D

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention