BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS MODULAR PROXIMAL FEMUR IMPLANT

    MDR report key: 4373079 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00184
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 20, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DETAILS PROVIDED CONFIRMED THAT THESE ITEMS ARE KEPT AT THE HOSPITAL ON CONSIGNMENT. THEY ARE SENT OUT OF THE HOSPITAL FOR THE STERILISATION PROCESS. THE GRUB SCREWS ARE NOT DESIGNED TO BE REMOVED AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED. IT IS POSSIBLE THAT THESE SCREWS ARE BEING REMOVED DURING THE CLEANING AND STERILISING PROCESS, WHICH IS LOOSENING THEM DURING USE, HOWEVER THIS CANNOT BE CONFIRMED WITH THE CURRENT AVAILABLE INFORMATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING GRUB SCREWS ALLEGEDLY BECOMING LOOSE ON PROXIMAL FEMUR METS STEMS TRIALS WAS REPORTED. THE EVENT COULD NOT BE CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS PRODUCT WAS NOT RETURNED. MEDICAL RECORDS EVALUATION WAS NOT PERFORMED AS MEDICAL INFORMATION WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN 5 OTHER SIMILAR EVENTS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION AND PRODUCT RETURN WERE REQUESTED HOWEVER IT WAS NOT PROVIDED. THE GRUB SCREWS ARE NOT DESIGNED TO BE REMOVED. THE TRIAL SETS ARE SENT OUT TO BE CLEANED/STERILISED AND IT IS UNKNOWN IF THE GRUB SCREWS ARE LOOSENED DURING THE CLEANING STERILISATION PROCESS. 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 WAS CORRECTED FROM "PROXIMAL FEMUR IMPLANT" TO "LIMB SALVAGE SYSTEM".

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE THEATRE LEAD THAT THERE IS A CONCERN WITH THE GRUB SCREWS IN THE TRIAL STEMS IN THE METS MODULAR PROXIMAL FEMUR KIT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE THEATRE LEAD THAT THERE IS A CONCERN WITH THE GRUB SCREWS IN THE TRIAL STEMS IN THE METS MODULAR PROXIMAL FEMUR KIT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00184 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851613 METS MODULAR PROXIMAL FEMUR IMPLANT LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other