BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4373084 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00212
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    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

    THE CAUSE OF THE UNCERTAINTY OF THE SHIPMENT WAS AN OVERLY AGGRESSIVE COMMITMENT DATE FOR THE MANUFACTURE OF THE IMPLANT, WHICH WAS ASSIGNED AT THE TIME OF ORDER ENTRY, WITH INSUFFICIENT DETAIL AS TO THE DESIGN REQUIREMENTS OF THE IMPLANT. AS A RESULT, STANMORE IS NOW COMMITTING TO MANUFACTURING AND RELEASE DATES FOR CUSTOM IMPLANTS, AFTER THE DESIGN REQUIREMENTS ARE FULLY UNDERSTOOD AND DOCUMENTED. 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. DATE OF EVENT WAS INCORRECTLY RECORDED AS (B)(6) 2014. COMMON DEVICE NAME CORRECTED FROM CUSTOM DISTAL FEMUR IMPLANT TO LIMB SALVAGE SYSTEM.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. AS THE INVESTIGATION IS ONGOING IT IS NOT POSSIBLE TO COMMENT ON THE ROOT CAUSE OF THE DELAYED DELIVERY AT THIS TIME. 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 PROXIMAL FEMUR IMPLANT (K121056).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT THE IMPLANT THAT WAS REQUIRED FOR THE PROCEDURE WAS NOT READY IN TIME FOR THE START OF THE PROCEDURE. THE PROCEDURE WAS POSTPONED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT THE IMPLANT THAT WAS REQUIRED FOR THE PROCEDURE WAS NOT READY IN TIME FOR THE START OF THE PROCEDURE. THE PROCEDURE WAS POSTPONED. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00212 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851798 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME19009

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other