BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    MDR report key: 4548134 · Received February 18, 2015

    Report

    Report Number
    3004105610-2015-00017
    Event Type
    Malfunction
    Date Received
    February 18, 2015
    Date of Event
    January 22, 2015
    Report Date
    January 22, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MORE EVENT RELATED INFORMATION HAS BEEN REQUESTED. THIS INVESTIGATION IS ONGOING AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO PATIENT SPECIFIC DISTAL FEMORAL ((B)(4)).

    Additional Manufacturer Narrative · 1

    THE CUSTOM MADE DEVICE WAS MADE SPECIFICALLY IN ACCORDANCE WITH THE DULY QUALIFIED MEDICAL PRACTITIONER'S WRITTEN PRESCRIPTION WHICH GIVES, UNDER HIS RESPONSIBILITY, SPECIFIC DESIGN CHARACTERISTICS. THE DESIGN PROPOSAL CONTAINING THE CHARACTERISTICS SUCH AS THE DIMENSIONS OF THE TIBIAL COLLAR AND POSTERIOR PLATES WERE REVIEWED AND APPROVED BY THE SURGEON AS PER (B)(4), AND THERE WAS NO NON-CONFORMANCE TO THE SURGEON VALIDATED DESIGN. THE PATIENT UNDERWENT SUCCESSFUL REVISION OF THE CUSTOM DISTAL FEMUR JTS. THE PATIENT WAS A (B)(6) BOY WITH OSTEOSARCOMA. FOLLOWING THE PROCEDURE, NO ADVERSE CONSEQUENCES WERE REPORTED. IN THIS CASE, TWO DESIGNERS FROM STANMORE IMPLANTS AND THE SURGEON REVIEWED AND CONCURRED THAT THE UNCEMENTED STEM DESIGN FOR EACH PATIENT WAS SUITABLE FOR THAT PATIENT PRIOR TO MANUFACTURE AND SUPPLY. A REVIEW OF THE DEVICE MANUFACTURING HISTORY RECORDS CONFIRMED THAT THE CUSTOM DEVICE WAS MANUFACTURED TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. THE CT SCANS PROVIDED FOR DESIGN PURPOSES WERE RE-REVIEWED. IT WAS CONFIRMED THAT THERE ARE NO APPARENT SCALING OR OTHER IMAGING ISSUES OBSERVED AS A RESULT OF THE RE-REVIEW. IT IS IMPORTANT TO NOTE THAT WHEN DESIGNING AN UNCEMENTED STEM FOR A YOUNG CHILD, UNDERSIZING THE STEM IS A KNOWN RISK AS THESE YOUNG PATIENTS TYPICALLY HAVE THIN CORTICES. THUS WITH THIS AGE PATIENT, THERE IS A COMPROMISE BETWEEN TAKING AWAY BONE AND REDUCING THE STRENGTH OF THE BONE SHAFT. THE STEM SIZE IS CRITICAL AS AN INCREASED SIZED STEM CAN WEAKEN THE CORTICES, PARTICULARLY IN THIS AGE PATIENT GIVEN THE PRESENCE OF THIN CORTICES. YOUNG CHILDREN WHO SUFFER FROM OSTEOSARCOMA AND WHO ARE UNDERGOING RADIOTHERAPY ARE AT GREATER RISK FOR BONE FRACTURE AS A RESULT OF THEIR BONES BECOMING EMBRITTLED FROM THE THERAPY. THUS IN THESE TYPE OF PATIENTS, THE DESIGNS OF UNCEMENTED STEMS MAY TEND TOWARD THE SMALLER/CONSERVATIVE SIDE TO AVOID POTENTIAL BONE FRACTURE. WHILE NO DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE COMPLAINT AS REPORTED, THE PATIENT'S AGE AND THIN CORTICES LIKELY CONTRIBUTED TO THE REPORTED ISSUE, AND CASE COMPLEXITY. 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. CORRECTED DATA - (B)(6). DEVICE: CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT CORRECTED TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT. DISTAL FEMUR IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM. EXPIRATION DATE CORRECTED FROM 05/20/2015 TO 05/21/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE UNCEMENTED STEM FOR THE CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT WAS DESIGNED TOO SMALL AND THE SURGEON HAD TO CEMENT IT IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE UNCEMENTED STEM FOR THE CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT WAS DESIGNED TOO SMALL AND THE SURGEON HAD TO CEMENT IT IN PLACE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00017 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116493 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME19002 PIN 19002

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention