BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE HFX SIZE #5

    MDR report key: 3603412 · Received February 3, 2014

    Report

    Report Number
    0002249697-2014-00249
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING OFF LABEL USE INVOLVING AN ACCOLADE HFX WAS REPORTED. THE DEVICE WAS RETURNED. THE ACCOLADE HFX STEM WAS RETURNED FOR ANALYSIS. THE BULLET TIP OF THE SPECIALTY OFFSET ACCOLADE STEM INSERTER WAS RETURNED FIRMLY STUCK IN THE STEM. IT APPEARED THE TIP OF THE INSERTER WAS ONLY INSERTED INTO THE STEM ABOUT HALF WAY. THERE ARE A FEW MARKS ON THE DISTAL PORTION OF THE STEM. CONCLUSION: IT WAS REPORTED THAT WHILE IMPACTING AN ACCOLADE HFX STEM WITH THE SPECIALTY ACCOLADE OFFSET STEM INSERTER THE INSTRUMENT BECAME LODGED AND STUCK IN THE STEM. A REVIEW OF THE SURGICAL PROTOCOL FOR THE ACCOLADE SYSTEM AND A REVIEW OF THE SURGEON APPROVAL LETTER FOR THE SPECIALTY ACCOLADE OFFSET STEM INSERTER INDICATED THIS INSTRUMENT IS NOT TO BE USED WITH THE ACCOLADE HFX STEM; THEREFORE, THIS APPLICATION OF THE DEVICE IS OFF LABEL USE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHILE IMPACTING AN ACCOLADE HFX STEM, A CUSTOM BROACH HANDLE WAS USED AND BECAME LODGED AND STUCK IN THE THE STEM DURING IMPACTION. WE OPENED ANOTHER STEM AND USED A THREAD IN IMPACTOR WITHOUT ANY FURTHER ISSUES.

    Description of Event or Problem · 1

    WHILE IMPACTING AN ACCOLADE HFX STEM, A CUSTOM BROACH HANDLE WAS USED AND BECAME LODGED AND STUCK IN THE THE STEM DURING IMPACTION. WE OPENED ANOTHER STEM AND USED A THREAD IN IMPACTOR WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70098 ACCOLADE HFX SIZE #5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MLEWDK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other