BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4364977 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00112
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    August 27, 2012
    Report Date
    September 12, 2012
    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

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCE WERE IDENTIFIED. AS THE DEVICE HAS BEEN IMPLANTED FOR 20 YEARS IT IS LIKELY THAT THE WEAR OF THE BUSHES IS RELATED TO NORMAL WEAR AND TEAR OF THE DEVICE, HOWEVER, THIS CANNOT BE CONFIRMED WITH THE CURRENT AVAILABLE INFORMATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Additional Manufacturer Narrative · 1

    A REBUSHING PROCEDURE WAS SUCCESSFULLY PERFORMED TO A DISTAL FEMUR IMPLANT, AFTER 20 YEARS IN-SITU, WITH NO REPORTED COMPLICATIONS. REBUSHING IS AN ANTICIPATED EVENT OVER THE LIFETIME OF AN ORTHOPAEDIC IMPLANT, CONSISTING OF THE REPLACEMENT OF POLY COMPONENTS WHICH ARE SUSCEPTIBLE TO WEAR, SUCH AS BEARINGS AND BUSHINGS, IN ADDITION TO THE AXLE AND RELATED RETAINING MECHANISMS. AS THE DEVICE REMAINED IN THE PATIENT AND NO EXPLANTED COMPONENTS WERE RETURNED IT IS NOT POSSIBLE TO ASSESS THE ACTUAL IMPLANT. A REVIEW OF THE BATCH RECORDS REVEALED NO EVIDENCE THAT NON-CONFORMING PRODUCTS WERE RELEASED FROM THIS BATCH THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED. CORRECTION: (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 1992 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 AS A REBUSHING WAS REQUIRED.

    Description of Event or Problem · 1

    SUPPLEMENTAL REPORT TO 3004105610-2014-00112 (SIW-(B)(4)). IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 1992 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 AS A REBUSHING WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839329 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD BME2245

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention