BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE TMZF HIP STEM #4

    MDR report key: 3852171 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02130
    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
    MEH
    PMA / PMN Number
    K994366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING AN ACCOLADE TMZF STEM THAT SAT PROUD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    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
    329803 ACCOLADE TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 45027701

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other