BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4361023 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00069
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    February 27, 2012
    Report Date
    February 16, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. 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 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 REBUSHING PROCEDURE ON (B)(6) 2006 AND SUBSEQUENTLY UNDERWENT A SECOND REBUSHING PROCEDURE ON (B)(6) 2012.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00069 ((B)(4)). IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A REBUSHING PROCEDURE ON (B)(6) 2006 AND SUBSEQUENTLY UNDERWENT A SECOND REBUSHING PROCEDURE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837989 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD BME12671

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention