BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITRAX V40 SLEEVE +0MM (STD)

    MDR report key: 3682262 · Received March 17, 2014

    Report

    Report Number
    0002249697-2014-00778
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K954077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ASSEMBLY ISSUES INVOLVING A UNITRAX SLEEVE TO AN UNKNOWN STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. A COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE DEVICE IS NEEDED FOR EVALUATION. THE STEM WAS NOT REPORTED AND IT IS UNKNOWN IF IT IS A STRYKER DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SALES AGENT REPORTED: "AT HOSPITAL (B)(6) THE SURGEON HAS PERFORMED AN URGENT SURGERY FOR A FEMUR FRACTURE. A CEMENTED ABG II WITH UNITRAX MODULAR ENDO HEAD HAVE BEEN IMPLANTED. IT WAS SELECTED AN UNITRAX MODULAR ENDO HEAD 45 WITH UNITRAX V40 SLEEVE +0MM (STD). IT WAS NOT POSSIBLE TO ASSEMBLY THE ENDO HEAD TO THE STEM, SURGEON DECIDED TO IMPLANT AN UNITRAX MODULAR ENDO HEAD 44 WITH UNITRAX V40 SLEEVE +4MM. IT WAS NOT POSSIBLE DISASSEMBLY THE UNITRAX MODULAR ENDO HEAD 45 FROM THE UNITRAX V40 SLEEVE +0MM (STD)".

    Description of Event or Problem · 1

    SALES AGENT REPORTED: "AT HOSPITAL PINNA PINTOR THE THE SURGEON HAS PERFORMED AN URGENT SURGERY FOR A FEMUR FRACTURE. A CEMENTED ABG II WITH UNITRAX MODULAR ENDO HEAD HAVE BEEN IMPLANTED. IT WAS SELECTED AN UNITRAX MODULAR ENDO HEAD 45 WITH UNITRAX V40 SLEEVE +0MM (STD). IT WAS NOT POSSIBLE TO ASSEMBLY THE ENDO HEAD TO THE STEM, SURGEON DECIDED TO IMPLANT AN UNITRAX MODULAR ENDO HEAD 44 WITH UNITRAX V40 SLEEVE +4MM. IT WAS NOT POSSIBLE DISASSEMBLY THE UNITRAX MODULAR ENDO HEAD 45 FROM THE UNITRAX V40 SLEEVE +0MM (STD)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157080 UNITRAX V40 SLEEVE +0MM (STD) IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH 42850605

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other