BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE TMZF FEMORAL RASP SIZE 4

    MDR report key: 3852174 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02129
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN ACCOLADE TMZF STEM THAT SAT PROUD INVOLVING AN ACCOLADE TMZF RASP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. HOSPITAL KEPT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INITIAL SURGERY OF RIGHT HIP, THE DOCTOR BROACHED UP TO #4. THE BROACH SET WHERE HE WANTED IT. WHEN THE STEM WAS IMPLANTED IT SAT PROUD ABOUT 5MM. IT THEN TWISTED INTO MORE INVERSION THAN BROACH. THIS LED TO A 30 MINUTE DELAY IN SURGERY. HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INITIAL SURGERY OF RIGHT HIP, THE DOCTOR BROACHED UP TO #4. THE BROACH SET WHERE HE WANTED IT. WHEN THE STEM WAS IMPLANTED IT SAT PROUD ABOUT 5MM. IT THEN TWISTED INTO MORE INVERSION THAN BROACH. THIS LED TO A 30 MINUTE DELAY IN SURGERY. HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329804 ACCOLADE TMZF FEMORAL RASP SIZE 4 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH MHHM7N

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other