BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TOTAL FEMUR REPLACEMENT

    MDR report key: 4938980 · Received July 24, 2015

    Report

    Report Number
    3004105610-2015-00065
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE COMPANY HAS REQUESTED ADDITIONAL DETAILED INFORMATION FROM THE SURGEON REGARDING THE REPORTED EVENT. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN THE FINAL REPORT. THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR TOTAL FEMUR IMPLANT (K121055). IMPLANTED.

    Additional Manufacturer Narrative · 1

    WHILE THE SURGEON WAS PLEASED WITH THE OUTCOME OF THE IMPLANT PROCEDURE, THE SURGEON SUGGESTED THAT STANMORE IMPLANTS RECOMMEND USE OF A "LOW" VISCOSITY CEMENT DURING CUSTOM TOTAL FEMUR IMPLANT PROCEDURES. STANMORE IMPLANTS DOES NOT MAKE ANY RECOMMENDATIONS REGARDING USE OF A SPECIFIC CEMENT VISCOSITY WITH ITS IMPLANTS. CEMENT VISCOSITY DOES NOT AFFECT THE FUNCTIONALITY, OR EFFICACY OF THE FINISHED/ASSEMBLED IMPLANT. THE DECISION TO USE "LOW" OR "NORMAL" VISCOSITY CEMENT IN ORTHOPEDIC IMPLANTS IS BASED SOLELY UPON SURGEON PREFERENCE AND EXPERIENCE. THERE IS NO FAILURE OF THE DEVICE, PACKAGING OR LABELING. THIS COMPLAINT IS A RECOMMENDATION BASED UPON SURGEON PREFERENCE. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECORDED BY STANMORE IMPLANTS AND IS CONSIDERED TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON IS REPORTED TO HAVE EXPERIENCED DIFFICULTY CEMENTING THE COMPONENTS TOGETHER. AS A RESULT, THE SURGEON HAS SUGGESTED THAT THE COMPANY RECOMMEND USE OF LOW VISCOSITY CEMENT WITH CUSTOM TOTAL FEMUR DEVICES IN FUTURE.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTARY TO MDR 3004105610-2015-00065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483863 CUSTOM TOTAL FEMUR REPLACEMENT LIMB SPARING SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD PIN 19522 PIN 19522

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other