BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS EXTENDIBLE DISTAL FEMUR IMPLANT

    MDR report key: 4373440 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00166
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Additional Manufacturer Narrative · 1

    THE HOSPITAL IN QUESTION HAD AN INSTRUMENT KIT ON CONSIGNMENT. NO KIT WAS SUPPLIED WITH THIS DISTAL FEMUR JTS. THE INSTRUMENT KITS HAVE DIFFERENT TYPES OF REAMERS. THE REAMER TO WHICH THE COMPLAINT REFERS WAS NOT RETURNED TO STANMORE IMPLANTS WORLDWIDE (SIW) FOR EVALUATION. SIW IS UNABLE TO DETERMINE WHETHER THE RIGHT REAMER WAS USED BY THE SURGEON. IT IS ALSO THE RESPONSIBILITY OF THE HOSPITAL TO CORRECTLY MAINTAIN INSTRUMENT KITS ON CONSIGNMENT. NO ROOT CAUSE HAS BEEN DETERMINED FOR THIS COMPLAINT. 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. DISTAL FEMUR IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED BY THE SURGEON THAT THE PASSIVE TIBIAL REAMER DID NOT FIT IN THE TRIAL BASEPLATE. THE SURGEON HAD TO USE THE LUG DRILL TO OPEN THE BONE CANAL, THEN THE METAL CASED TIBIAL REAMER AND THE ALL POLY REAMER.

    Description of Event or Problem · 1

    DURING THE PROCEDURE IT WAS REPORTED BY THE SURGEON THAT THE PASSIVE TIBIAL REAMER DID NOT FIT IN THE TRIAL BASEPLATE. THE SURGEON HAS TO USE THE LUG DRILL TO OPEN THE BONE CANAL, THEN THE METAL CASE TIBIAL REAMER AND THE ALL POLY REAMER. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00166 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847344 JTS EXTENDIBLE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME18700

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R