BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373070 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00173
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    May 15, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    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 MANUFACTURING HISTORY CONFIRMS NON NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. BASED ON THE LENGTH OF TIME THE DEVICE HAS BEEN IMPLANTED IT IS LIKELY THAT THE REBUSHING PROCEDURE WAS REQUIRED DUE TO NORMAL WEAR AND TEAR OF THE DEVICE. 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 MET SMILES TOTAL KNEE REPLACEMENT IMPLANT (K120992).

    Additional Manufacturer Narrative · 1

    A REBUSHING PROCEDURE WAS SUCCESSFULLY PERFORMED WITH NO REPORTED COMPLICATIONS. REBUSHING IS AN ANTICIPATED EVENT DUE TO THE NATURE AND DESIGN OF THE IMPLANT. 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 PROCEDURE ON (B)(6) 1999 AND SUBSEQUENTLY UNDERWENT A REBUSHING PROCEDURE ON (B)(6), 2014. REF: (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851792 CUSTOM DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME6305

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention