BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MID-SHAFT FEMUR

    MDR report key: 4373370 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00134
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    April 8, 2014
    Report Date
    February 22, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS REPORTED AS A CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT IN ERROR. THE ACTUAL DEVICE IN QUESTION IS A CUSTOM MID-SHAFT FEMUR. THIS DEVICE IS NOT MARKETED IN THE US THEREFORE THE EVENT WHICH OCCURRED IN (B)(6) IS NOT MDR REPORTABLE. CORRECTIONS BRAND NAME CORRECTED FROM CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT TO CUSTOM MID-SHAFT FEMUR. COMMON DEVICE NAME CORRECTED FROM CUSTOM DISTAL FEMUR IMPLANT TO LIMB SALVAGE SYSTEM.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. REPORTS FROM THE SURGEON SUGGEST THAT THE LOOSENING MAY BE RELATED TO THE PT'S POOR BONE QUAL. THE FRACTURE HAS MOST LIKELY OCCURRED DUE TO THE LOOSENING. IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE WITH THE CURRENT AVAILABLE INFO. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOMER IMPLANT IS SIMILAR TO THE METS PROXIMAL DISTAL FEMUR IMPLANT (K121056).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2010 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2013 DUE TO LOOSENING AND A PERI-PROSTHETIC FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2010 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2013 DUE TO LOOSENING AND A PERI-PROSTHETIC FRACTURE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00134 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847141 CUSTOM MID-SHAFT FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME15501

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention