BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 5079821 · Received September 14, 2015

    Report

    Report Number
    3004105610-2015-00073
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 20, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN ALLEGED SEAL INVOLVING A DISTAL FEMUR JTS WAS REPORTED. THE EVENT WAS NOT CONFIRMED AS THE PACKAGING WAS NOT RETURNED. DEVICE HISTORY REVIEW: A DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE PACKAGING WAS NOT RETURNED AND THE PHOTOGRAPHS PROVIDED SHOW INSUFFICIENT DETAIL AS THE PHOTOGRAPHS WERE TAKEN AFTER THE SURGERY. IN ORDER TO CONFIRM THIS EVENT A RETURNED PACKAGED PRODUCT WITH AN UNDISTURBED, AS RECEIVED, SEAL WILL BE REQUIRED. IT SHOULD ALSO BE NOTED THAT SINCE THE TIME OF THIS COMPLAINT A VALIDATION ON THE POUCH SEALER HAS BEEN PERFORMED. CORRESPONDENCE FROM THE REPORTER OF THE COMPLAINT STATE THE OUTER PACKAGING WAS CLOSED SECURELY AND THEREFORE THE IMPLANT STERILITY WAS NOT COMPROMISED. 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: EXPIRATION DATE WAS CORRECTED FROM 08-06-2015 TO 01-08-2016.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFR'G HISTORY RECORDS SHOWED THAT THE DEVICE WAS PACKAGED ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO NON CONFORMITIES ASSOCIATED W/TH DEVICE IN QUESTION. THE DISTAL FEMUR JTS IS ENCLOSED IN 3 SEPARATE POUCHES. IT W AS REPORTED THAT THE MIDDLE POUCH SEAL HAD FAILED AND THERE WAS A BREACH. THE OUTER AND THE INNER POUCHES WERE STILL INTACT, AND THE STERILITY OF THE DEVICE WAS NOT COMPROMISED. AS THE DEVICE WAS STERILE THE SURGEON CONTINUED W/THE SURGERY, PROVIDING PHOTOGRAPHS OF THE PACKAGING. BY WAY OF BACKGROUND, BEFORE THE DEVICE IS SEALED INTO ITS' INDIVIDUAL POUCH, THE POUCH SEALING PROCESS IS CONFIRMED TO ASSURE IT PROVIDES A COMPLETE, CONTINUOUS SEAL. SAMPLES OF POUCH SEALS ARE MAINTAINED IN ARCHIVES. THE ARCHIVED SETS OF SEALS WERE INSPECTED, AND OBSERVED TO BE COMPLETELY INTACT. THE INVESTIGATION IS ONGOING AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFECTIVE SEAL WAS OBSERVED ON AN INNER POUCH OF THE JTS DISTAL FEMUR DEVICE. NO ADVERSE EVENT OR DELAY TO SURGERY WAS REPORTED. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00073 ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFECTIVE SEAL WAS OBSERVED ON AN INNER POUCH OF THE JTS DISTAL FEMUR DEVICE. NO ADVERSE EVENT OR DELAY TO SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606077 CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 19477 PIN 19477

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR