BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 3870615 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02267
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING TRUNIONOSIS AND ELEVATED METAL IONS INVOLVING AN UNKNOWN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW AND CHR COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE (B)(4) PRODUCT MANAGER FOR HIPS THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2014 DUE TO REPORTED TRUNNIONS. THE SURGEON REPORTED THAT THE FEMALE PATIENT ALSO HAD HIGH METAL ION LEVELS FOLLOWING BLOOD TESTS AND THAT HER LEFT ACCOLADE / TRIDENT HIP REPLACEMENT APPEARED LOOSE ON X-RAY.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE (B)(4) PRODUCT MANAGER FOR HIPS THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2014 DUE TO REPORTED TRUNIONOSIS. THE SURGEON REPORTED THAT THE FEMALE PATIENT ALSO HAD HIGH METAL ION LEVELS FOLLOWING BLOOD TESTS AND THAT HER LEFT ACCOLADE / TRIDENT HIP REPLACEMENT APPEARED LOOSE ON X-RAY. THE PATIENT HAS THE SAME DEVICE COMBINATION IMPLANTED IN HER RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347849 UNKNOWN_CORK_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R