BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METS DISTAL FEMUR STEM CURVED

    MDR report key: 6522226 · Received April 26, 2017

    Report

    Report Number
    3004105610-2017-00031
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    April 3, 2017
    Report Date
    June 1, 2017
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ONE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 19TH APR, 2011 WITH NO REPORTED DISCREPANCIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE LOOSENING OF THE STEM WAS CONFIRMED BY X-RAY REVIEW. CASE REVIEW CONFIRMED THAT, CONTRARY TO THE INSTRUCTIONS PROVIDED FOR THIS DEVICE, THE IN-SITU STEM HAD BEEN ALTERED BY CUTTING THE TIP OF THE STEM OFF AND AS SUCH IS CONSIDERED TO BE OFF LABEL USE. THE EXACT CAUSE OF THE REPORTED LOOSENING COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE (SIW). AS REQUESTED A CUSTOM REVISION IMPLANT HAS BEEN DESIGNED AND SUPPLIED TO THE SURGEON FOR THE REVISION PROCEDURE, STANMORE IMPLANTS HAVE NOT BEEN INFORMED OF THE DATE THE REVISION PROCEDURE WILL BE COMPLETED. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING CORRECTIONS WERE MADE: PRODUCT NAME WAS CORRECTED FROM 'JTS DISTAL FEMUR SMILES' TO 'METS DISTAL FEMUR STEM'. LOT NUMBER WAS CORRECTED FROM PIN 15789 TO B14172. EXPIRY DATE WAS CORRECTED FROM 03/31/2012 TO 07/31/2020. PMA/510(K)# WAS CORRECTED FROM K133152 TO K121029. MANUFACTURE DATE WAS CORRECTED FROM 04/19/2011 TO 08/26/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRESCRIPTION FROM WAS RECEIVED FOR A NEW IMPLANT DUE TO A STRESS RISER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRESCRIPTION FORM WAS RECEIVED FOR A NEW IMPLANT DUE TO A STRESS RISER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304616 METS DISTAL FEMUR STEM CURVED LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE B14172

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR