BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACCOLADE STEM

    MDR report key: 6013542 · Received October 10, 2016

    Report

    Report Number
    0002249697-2016-03194
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE DEVICE WAS NOT RETURNED FOR EVALUATION. AN EVENT REGARDING CORROSION INVOLVING AN UNKNOWN ACCOLADE TMZF STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE DETAILS, DEVICE ANALYSIS, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON STATED HE WAS REVISING AN ACCOLADE TMZ STEM. WHEN HE REMOVED THE METAL HEAD HE FELT THERE WAS AN AMOUNT OF CORROSION ON THE TAPER. HE REVISED THE POLY LINER AND FELT THERE WAS SIGNIFICANT OXIDATION. THERE APPEARED TO BE YELLOWING OF THE LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON STATED HE WAS REVISING AN ACCOLADE TMZ STEM. WHEN HE REMOVED THE METAL HEAD HE FELT THERE WAS AN AMOUNT OF CORROSION ON THE TAPER. HE REVISED THE POLY LINER AND FELT THERE WAS SIGNIFICANT OXIDATION. THERE APPEARED TO BE YELLOWING OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664811 UNKNOWN ACCOLADE STEM HIP IMPLANT JDG STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention