BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE STEM INSERTER

    MDR report key: 3781316 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01619
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN (B)(4) OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. A PHOTOGRAPH OF THE BROKEN INSERTER WAS PROVIDED INDICATING THAT A PORTION OF THE INSERTER TIP IS MISSING. THE EVENT WAS CONFIRMED BY A PHOTOGRAPH OF THE DAMAGED INSERTER. HOWEVER, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS A PRIMARY LEFT THA. THE SURGEON TOOK AN INTRAOPERATIVE AP FILM BEFORE CLOSING THE PATIENT WHICH APPEARED NORMAL. A POST OP FILM WAS TAKEN AFTER THE SURGERY DURING RECOVERY AND WHERE THE THREADED HOLE IS ON TOP OF THE STEM, THERE APPEARS TO BE A METAL TAB REMAINING IN THE PATIENT. THE SURGEON SUSPECTED THE STEM INSERTER AND AFTER INSPECTING THE INSTRUMENT, IT WAS FOUND THAT A METAL TAB IS MISSING FROM IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS A PRIMARY LEFT THA. THE SURGEON TOOK AN INTRAOPERATIVE AP FILM BEFORE CLOSING THE PATIENT WHICH APPEARED NORMAL. A POST OP FILM WAS TAKEN AFTER THE SURGERY DURING RECOVERY AND WHERE THE THREADED HOLE IS ON TOP OF THE STEM, THERE APPEARS TO BE A METAL TAB REMAINING IN THE PATIENT. THE SURGEON SUSPECTED THE STEM INSERTER AND AFTER INSPECTING THE INSTRUMENT, IT WAS FOUND THAT A METAL TAB IS MISSING FROM IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259029 ACCOLADE STEM INSERTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH BPZW02

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other