BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS MODULAR DISTAL FEMUR

    MDR report key: 4373035 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00191
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 5, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED STICKY SPOTS AND SOME LABELS ADHERING TO A METS DISTAL FEMUR INSTRUMENT TRAY WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DISTAL FEMUR METS INSTRUMENT TRAY WAS INSPECTED AT THE DISTRIBUTOR'S PREMISES IN (B)(4) AND FOUND TO BE STICKY AND HAD SOME LABELS ADHERING TO THE TRAY. STANMORE INSPECTS ALL INSTRUMENTATION WHICH IS RETURNED, BOTH PRE AND POST CLEANING, AND RECORDS OF RESULTS ARE MAINTAINED. THE KIT WAS RE-CLEANED AT THE DISTRIBUTORS IN (B)(4) BEFORE IT WAS SENT TO THE HOSPITAL. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE IMPLANTS WORLDWIDE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA COMMON DEVICE NAME/PRODUCT CODE WAS CORRECTED FROM "DISTAL FEMUR IMPLANT" TO "LIMB SALVAGE SYSTEM/KRO". LABELLED FOR SINGLE USE WAS CORRECTED FROM "YES" TO "NO" AS THE TRAYS ARE RE-USABLE.

    Additional Manufacturer Narrative · 1

    REQUESTS ARE BEING MADE FOR ADD'L INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE DISTAL FEMUR KITS WERE STICKY AND REQUIRED RE-CLEANING BEFORE USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE DISTAL FEMUR KITS WERE STICKY AND REQUIRED RE-CLEANING BEFORE USE. NOTE: THE INCIDENT REFERS TO METS DISTAL FEMUR INSTRUMENT TRAYS. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00191 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850713 METS MODULAR DISTAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA