BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 4380004 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00117
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT X-RAY IMAGES CONFIRMED THE COMPLAINT. A REVISION PROCEDURE WAS PERFORMED WITH NO REPORTED COMPLICATIONS, WITH A NEW CIRCLIP BEING PLACED. AS THE EXPLANTED CIRCLIP WAS DISCARDED BY THE HOSPITAL NO FURTHER INFORMATION IS AVAILABLE. NO ROOT CAUSE COULD BE DETERMINED, ALTHOUGH A DETACHED CIRCLIP IS TYPICALLY THE RESULT OF AN INSERTION ISSUE AT THE TIME OF IMPLANT. THIS COMPLAINT IS BEING CLOSED, AND TRACKED AND TRENDED. PROSTHESIS, HIP, SEMI-CONSTRAINED CORRECTED TO LIMB SALVAGE SYSTEM. EXPIRATION DATE CORRECTED FROM 10/11/2015 TO 10/11/2014.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PATIENT'S X-RAYS CONFIRMS THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE COMPLAINT INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN FURTHER INFORMATION IS AVAILABLE. PLEASE NOTE THAT THE CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO THE METS MODULAR TOTAL FEMUR IMPLANT (K121055).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT PROCEDURE ON (B)(6) 2014. THE SURGEON IS NOW REPORTING THAT "THE PATIENT'S KNEE FEELS UNSTABLE." HE IS ALSO REPORTING THE PATINT'S RECENT X-RAYS CONFIRM THAT THE IMPLANT "AXLE HAS BACKED OUT." A REVISION PROCEDURE TO REPLACE THE CIRCLIP AND AXLE WAS TENTATIVELY SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT PROCEDURE ON (B)(6) 2014. THE SURGEON IS NOW REPORTING THAT "THE PATIENT'S KNEE FEELS UNSTABLE." HE IS ALSO REPORTING THE PATIENT'S RECENT X-RAYS CONFIRM THAT THE IMPLANT "AXLE HAS BACKED OUT." A REVISION PROCEDURE TO REPLACE THE CIRCLIP AND AXLE WAS TENTATIVELY SCHEDULED FOR (B)(6) 2014. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00117 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847489 CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD BME18658 PIN 18658

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention