BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUSHING/HOUSING

    MDR report key: 3214022 · Received July 9, 2013

    Report

    Report Number
    0002249697-2013-02238
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OBSERVATION OF THE DEVICE BY THE MATERIAL ANALYSIS TEAM INDICATED THE DISCOLORATION IS NOT INDICATIVE OF ANY MATERIAL OR MANUFACTURING DEFECTS. A FUNCTIONAL ANALYSIS INDICATED THAT THERE WAS SOME DIFFICULTY DURING INSERTION OF A RETURNED SHAFT WITH THE BUSHING. ALTHOUGH THERE WAS INITIAL RESISTANCE FROM BUSHING DAMAGE, THE DEVICE FUNCTIONED PROPERLY WHEN FULLY ENGAGED. THE REPORTED FAILURE WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES MET SPECIFICATION AT THE TIME OF MANUFACTURE. COMPLAINT HISTORY REVIEW FOUND THERE HAVE BEEN OTHER EVENTS FOR THE SUBJECT DEVICE LOT. THE EVENTS WERE ATTRIBUTED TO POOR MAINTENANCE OF THE DEVICE OVER SEVERAL YEARS OF USE. THE INVESTIGATION CONCLUDED THAT THE LIKELY CAUSE OF THE REPORTED DAMAGE IS USER MISUSE. IT IS LIKELY THAT THE DEVICE WAS NOT PROPERLY CLEANED BETWEEN USES, WHICH LED TO THE BUILD UP OF DEBRIS, CAUSING THE DAMAGE THREADS. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE IS CONSIDERED FUNCTIONALLY ACCEPTABLE. RESISTANCE WAS NOTED INITIALLY, BUT WHEN FULLY ENGAGED, THERE WERE NO ISSUES. NO MATERIAL OR MANUFACTURING DEFECTS WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REAMAER SHAFT AND BUSHING ASSEMBLY STUCK DURING REAMING THE PATELLA. THE SURGEON STOPPED USING THEM AND CUT FREEHAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REAMER SHAFT AND BUSHING ASSEMBLY STUCK DURING REAMING THE PATELLA. THE SURGEON STOPPED USING THEM AND CUT FREEHAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313053 BUSHING/HOUSING INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other