BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR

    MDR report key: 4168377 · Received October 9, 2014

    Report

    Report Number
    3004105610-2014-00029
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FRACTURE WAS NOT CONFIRMED VIA X-RAY. THE PATIENT WALKED WITH A LIMP, THERE WAS NO CONCLUSION AS TO WHETHER A DEVICE FRACTURE OCCURRED. THERE HAS BEEN NO FOLLOW-UP BY THE SURGEON REQUESTING FURTHER DESIGN INPUT. THIS COMPLAINT WILL BE CLOSED. IF FURTHER CONTACT BY THE SURGEON IS MADE, STANMORE WILL INVESTIGATE AND PROVIDE AN UPDATE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING; ADDITIONAL INFO HAS BEEN REQUESTED. ALSO, THE COMPANY HAS REQUESTED THAT THE DEVICE BE RETURNED TO THE COMPANY FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED. NOTE: THIS CUSTOM DEVICE IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Description of Event or Problem · 1

    IN AN EMAIL DATED (B)(4)2014, THE SURGEON REPORTED A COMPLAINT TO THE COMPANY REGARDING A PT WITH A GROWING PROXIMAL FEMUR. "HE HAS A BIT SHORT ON THAT SIDE, BUT THAT HAS BEEN THE SAME FOR YEARS (YOU WILL SEE THAT WE PUT CEMENT IN TO STOP IT COLLAPSING FURTHER). HE HAS RECENTLY STARTED LIMPING A LOT MORE AND THIS X-RAY LOOKS AS THOUGH THERE MAY BE A LUCENT LINE BETWEEN THE STEM AND THE SHAFT-IS THIS REAL-SI THIS A FRACTURE? I COULD NOT DETECT ANY MOVEMENT THERE - WHAT DO YOU THINK?" A PHOTO OF THE PT'S X-RAY WAS PROVIDED TO THE COMPANY.

    Description of Event or Problem · 1

    (B)(4). THE PATIENT WAS ORIGINALLY TREATED FOR EWING'S SARCOMA IN LEFT PROXIMAL FEMUR IN (B)(6) 2003, WITH A STANMORE IMPLANT'S CUSTOM PROXIMAL FEMUR REPLACEMENT DEVICE. IN AN EMAIL DATED (B)(6) 2014, THE SURGEON REPORTED A COMPLAINT TO THE COMPANY REGARDING A PATIENT WITH A GROWING PROXIMAL FEMUR. "HE HAS A BIT SHORT ON THAT SIDE, BUT THAT HAS BEEN THE SAME FOR YEARS (YOU WILL SEE THAT WE PUT CEMENT IN TO STOP IT COLLAPSING FURTHER). HE HAS RECENTLY STARTED LIMPING A LOT MORE AND THIS X-RAY LOOKS AS THOUGH THERE MAY BE A LUCENT LINE BETWEEN THE STEM AND THE SHAFT-IS THIS REAL-IS THIS A FRACTURE? I COULD NOT DETECT ANY MOVEMENT THERE -WHAT DO YOU THINK?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635415 CUSTOM PROXIMAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME10272 BME10272

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other