BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE STEM INSERTER

    MDR report key: 5457773 · Received February 24, 2016

    Report

    Report Number
    0002249697-2016-00539
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    January 29, 2016
    Report Date
    January 29, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN ACCOLADE STEM INSERTER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: NO OTHER EVENTS WERE REPORTED FOR THE LOT INDICATED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP OF LOCK IN HFX STEM IMPACTOR FRACTURED UPON IMPACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP OF LOCK IN HFX STEM IMPACTOR FRACTURED UPON IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113802 ACCOLADE STEM INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH BP1L03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other