BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEONICS UNIV. DISTAL SPACER

    MDR report key: 4222792 · Received November 4, 2014

    Report

    Report Number
    0002249697-2014-04120
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K914406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT. ONLY THE PROXIMAL TIP OF THE OSTEONICS UNIVERSAL DISTAL SPACER WAS RETURNED. MACROSCOPIC FEATURES OF THE FRACTURES SURFACE WERE CONSISTENT WITH OVERLOAD. THE INVESTIGATION DETERMINED THE CENTRALIZER FRACTURED IN OVERLOAD. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CENTRALISER THAT FITS ON THE END OF THE OMNIFIT STEM BROKE OFF AS SURGEON WAS IMPLANTING THE OMNIFIT 127DEG STEM. SURGEON SAYS HE WASN'T PUSHING HARD BUT THE FLANGES BROKE OFF. THE SURGEON THEN REMOVED THE STEM AND TOOK WHAT WAS LEFT OF THE CENTRALISER OFF THE STEM AND REPLACED WITH A NEW CENTRALISER BEFORE IMPLANTING SUCCESSFULLY.

    Description of Event or Problem · 1

    THE CENTRALISER THAT FITS ON THE END OF THE OMNIFIT STEM BROKE OFF AS SURGEON WAS IMPLANTING THE OMNIFIT 127DEG STEM. SURGEON SAYS HE WASN'T PUSHING HARD BUT THE FLANGES BROKE OFF. THE SURGEON THEN REMOVED THE STEM AND TOOK WHAT WAS LEFT OF THE CENTRALISER OFF THE STEM AND REPLACED WITH A NEW CENTRALISER BEFORE IMPLANTING SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707496 OSTEONICS UNIV. DISTAL SPACER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH MNKJA8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other