BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR

    MDR report key: 4955723 · Received July 31, 2015

    Report

    Report Number
    3004105610-2015-00072
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CUSTOM DESIGN AND MANUFACTURING HISTORY RECORDS HAS CONFIRMED THE REPORTED DESIGN ERROR AND THE SUBSEQUENT MODIFICATION. A CAPA (B)(4) HAS BEEN RAISED TO INVESTIGATE THE ROOT CAUSE OF THE DESIGN ERROR. A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029). IMPLANTED.

    Description of Event or Problem · 1

    THE CUSTOM DISTAL FEMUR IMPLANT PROCEDURE WAS SCHEDULED FOR DISPATCH ON (B)(6) 2015. THE CUSTOM DEVICE WAS MANUFACTURED AND RELEASED PER THE DESIGN SPECIFICATION. HOWEVER, AFTER THE DEVICE WAS SHIPPED, BUT PRIOR TO ITS ARRIVAL AT THE CUSTOMER SITE, A DESIGN ERROR WAS IDENTIFIED WHICH RESULTED IN THE TIBIAL COMPONENT BEING DESIGNED AND MANUFACTURED TOO THIN IN RELATION TO THE MATING TIBIAL BEARING. THE DEVICE WAS RETURNED TO THE COMPANY, MODIFIED AND SHIPPED TO THE CUSTOMER ON (B)(6) 2015. THE PROCEDURE SUCCESSFULLY OCCURRED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502281 CUSTOM DISTAL FEMUR LIMB SPARING SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 19477 PIN 19477

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other