BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE FEMORAL REPLACEMENT IMPLANT

    MDR report key: 4707083 · Received April 10, 2015

    Report

    Report Number
    3004105610-2015-00047
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURING TO SPECIFICATION AND THAT NO NON-CONFORMITIES WERE IDENTIFIED. THE INVESTIGATION IS ONGOING, A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THE CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO MET5 MODULAR PROXIMAL FEMUR (K121056).

    Additional Manufacturer Narrative · 1

    AN IMPLANT DATING TO 1982 WAS REVISED WITH A PROXIMAL FEMUR AND AN ACETABULAR RECONSTRUCTION. AS THE IMPLANT WAS 33 YEARS OLD, THE REASON FOR REVISION IS ATTRIBUTED TO WEAR AND TEAR. THE COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE ASEPTIC LOOSENING COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER IT WAS NOT PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION. IT WAS NOTED THAT ON REVIEW OF THE RELEVANT DESIGN DOCUMENTATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE SUBJECT DEVICE WAS INCORRECTLY DESIGNED. 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.

    Description of Event or Problem · 1

    SURGEON HAS REQUESTED A REVISION FOR A CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT. THE REASON FOR THE REVISION IS NOT YET KNOWN.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00047 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2014. THE PATIENT UNDERWENT AN X-RAY WHICH CONFIRMED THAT THE UNCEMENTED FEMORAL STEM IS LOOSE AND IS AFFECTING THE PATIENT'S ABILITY TO WALK. A REVISION PROCEDURE IS SCHEDULED FOR LATE (B)(6) 2015. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00047 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240897 CUSTOM JTS NON-INVASIVE FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD MBE396

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention