BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3970125 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02942
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    April 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE STEM. ADDITIONALLY AN UNKNOWN MITCH CUP AND MITCH HEAD MANUFACTURED BY DEPUY WERE REPORTED. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ELEVATED COBALT AND POSSIBLE SYMPTOMS OF COBALT TOXICITY INVOLVING AN UNKNOWN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED. THIS EVENT IS UNDER THE SCOPE OF (B)(4), INITIATED IN RESPONSE TO THE FIELD SAFETY NOTICE FOR MITCH TRH CUP /HEAD WHEN IMPLANTED WITH THE UNCEMENTED ACCOLADE STEM. A REVIEW OF POST-MARKET SURVEILLANCE DATA SUGGESTED A HIGHER THAN EXPECTED REVISION RATE FOR THIS DEVICE COMBINATION. THE FIELD SAFETY NOTICE ADVISES AGAINST THIS COMBINATION AND RECOMMENDS PATIENTS BE FOLLOWED ACCORDING TO LOCAL GUIDANCE/STANDARD OF CARE FOR PATIENTS RECEIVING METAL ON METAL ARTICULATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COBALT LEVELS RISING ON BLOOD TESTS. POSSIBLY NEUROLOGICAL AND CARDIAC SYMPTOMS OF COBALT TOXICITY, PALPITATIONS TREMOR, BURNING FEET, ABNORMAL SMELL SENSATIONS, MILD DISORIENTATION AT TIMES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COBALT LEVELS RISING ON BLOOD TESTS. POSSIBLY NEUROLOGICAL AND CARDIAC SYMPTOMS OF COBALT TOXICITY, PALPITATIONS TREMOR, BURNING FEET, ABNORMAL SMELL SENSATIONS, MILD DISORIENTATION AT TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446812 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other