BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373451 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00163
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE REQUIREMENT FOR REBUSHING WAS MOST LIKELY RELATED TO THE LENGTH OF THE TIME THAT THE DEVICES HAVE BEEN IMPLANTED. THE INITIAL PROCEDURE WAS 15 YEARS AGO. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992).

    Additional Manufacturer Narrative · 1

    A REBUSHING PROCEDURE WAS SUCCESSFULLY PERFORMED WITH NO REPORTED COMPLICATIONS. REBUSHING IS AN ANTICIPATED EVENT OVER THE LIFETIME OF AN ORTHOPAEDIC IMPLANT, PERFORMED AT THE DISCRETION OF THE SURGEON. IT CONSISTS 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. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT IN 1999 AND SUBSEQUENTLY UNDERWENT A REBUSHING PROCEDURE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT IN 1999 AND SUBSEQUENTLY UNDERWENT A REBUSHING PROCEDURE ON (B)(6) 2014. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00163 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847325 CUSTOM DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 6737 PIN 6737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R