BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL KNEE REPLACEMENT (SUPER STABILISER)

    MDR report key: 4373060 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00202
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    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

    THE IMPLANT HAS NOT BEEN RETURNED FOR EVAL, THEREFORE, A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. IT IS LIKELY THAT THE FAILURE OF THE PLASTIC COMPONENT IS LINKED TO THE IMPLANTATION TIME OF 18 YEARS. REQUESTS ARE BEING MADE FOR ADD'L INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K120992).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE PLASTIC INSERT (REBUSHING), WITH NO REPORTED COMPLICATIONS, AFTER THE REPORTED DEVICE HAD BEEN IMPLANTED FOR 18 YEARS WITH THE POLY COMPONENT BEING REPLACED IN 2008 (6 YEARS PRIOR TO THE ALLEGED EVENT). THE EXACT CAUSE OF THE REPORTED REBUSHING PROCEDURE COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REBUSHING IS NOT AN UN-ANTICIPATED EVENT OVER THE LIFETIME OF AN ORTHOPAEDIC IMPLANT AND CONSISTS OF THE REPLACEMENT OF COMPONENTS WHICH ARE SUSCEPTIBLE TO WEAR. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE IMPLANTS WORLDWIDE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA - SP TKR CORRECTED TO TOTAL KNEE REPLACEMENT (SUPER STABILISER). TOTAL KNEE REPLACEMENT CORRECTED TO LIMB SALVAGE SYSTEM. OPERATOR OF DEVICE CORRECTED FROM HEALTH PROFESSIONAL TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT A PT REQUIRED A REVISION PROCEDURE DUE TO THE FAILURE OF THE PLASTIC INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT A PATIENT REQUIRED A REVISION PROCEDURE DUE TO THE FAILURE OF THE PLASTIC INSERT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00202 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851420 TOTAL KNEE REPLACEMENT (SUPER STABILISER) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME4047

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR