BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4534802 · Received February 17, 2015

    Report

    Report Number
    3004105610-2015-00014
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON USED A COMPETITORS REAMERS AND USED THE GENERAL PLIERS TO INSERT THE AXLE. THE INVESTIGATION IS ONGOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLEASE NOTE THAT THIS CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO PT SPECIFIC DISTAL FEMORAL ((B)(4)).

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT KIT (MODEL NUMBER: IMAXCP ((B)(4)), LOT NUMBER: B5334) WAS RETURNED TO STANMORE IMPLANTS WORLDWIDE LTD (SIW) FOR TESTING AND ANALYSIS. REGARDING THE CUSTOMER'S REPORT OF A MISSING PASSIVE TIBIAL EXTRA-SMALL REAMER IN THE CUSTOM INSTRUMENT KIT PROVIDED, STANMORE IMPLANT'S OLDER VERSION KITS DO NOT CONTAIN THIS REAMER. HISTORICALLY, HOSPITALS HAVE USED THEIR OWN "EXTRA SMALL" REAMERS FOR THESE PROCEDURES, WHICH IS WHAT OCCURRED IN THIS CASE. STANMORE IMPLANTS HAD INTRODUCED A NEWER VERSION INSTRUMENTATION KIT, WHICH INCLUDED PROVIDING PASSIVE TIBIAL EXTRA-SMALL REAMERS, AS AN ACCOMMODATION TO USERS. THE USER IN QUESTION HAD EARLIER RECEIVED A NEWER VERSION KIT, THEN RECEIVED AN OLDER VERSION KIT WHICH WAS STILL IN CIRCULATION, AND WHICH WAS STILL DEEMED FUNCTIONAL. REGARDING THE CUSTOMER'S REPORT THAT THE AXLE CAP INTRODUCER (ACI) WAS MISSING TWO PINS, AS NOTED ABOVE, THE INSTRUMENTATION KIT PROVIDED TO THE USER WAS THE OLDER VERSION KIT. THEREFORE, BY DESIGN, THE ACI WOULD NOT HAVE CONTAINED TWO PINS. THE NEWER VERSION INSTRUMENTATION KIT CONTAINS A MODIFIED ACI, WHICH DOES CONTAIN TWO PINS. THE MODIFICATIONS TO THE INSTRUMENTATION KIT WERE PROVIDED AS AN ACCOMMODATION TO THE USER. THUS THE DISPOSITION DECISION OF THE OLDER VERSION KIT AT THE TIME THE NEWER VERSION WAS RELEASED, WAS TO CONTINUE TO USE THE OLDER VERSION KITS, AND TO PHASE OUT USAGE OF THESE KITS OVER TIME THROUGH OBSOLESCENCE. THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THERE WAS AN EXTRA SMALL REAMER MISSING IN THE KIT AND THE AXLE CAP INSTRUMENT WAS MISSING THE 2 PINS THAT IS REQUIRED TO INSERT THE AXLE.

    Description of Event or Problem · 1

    SUPPLEMENTAL REPORT TO MDR # 3004105610-2015-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112300 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT CUSTOM DISTAL FEMUR KRO STANMORE IMPLANTS WORLDWIDE LTD. BME19116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR